FDA Product Code
FDA Product Code DSA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2900
510(k) Clearances — 105 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254114 | Baylis Connector Cable | Baylis Medical Technologies, Inc. | 2026-01-18 | Special | PDF ↗ |
| K252827 | IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559) | Drägerwerk AG & Co. KGaA | 2025-12-01 | Traditional | PDF ↗ |
| K251669 | IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapter | Shanghai Draeger Medical Instrument Co., Ltd. | 2025-09-30 | Traditional | PDF ↗ |
| K242986 | SpO2 Extension Cable | Beijing Rongrui-Century Science & Technology Co., Ltd. | 2025-05-02 | Special | PDF ↗ |
| K243545 | Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC; 989803170181, OR 5-Lead ECG Trunk Cable, AAMI/IEC; M1667A, 6 Lead ECG Trunk, AAMI/IEC 2.7m; M1668A,5 Lead ECG Trunk, AAMI/IEC 2.7m; M1669A,3 Lead ECG Trunk, AAMI/IEC 2.7m; M1949A,5+5 ECG Trunk cable AAMI, IEC 2.7m; M1663A,10 Lead ECG Trunk AAMI/IEC 2m; M1665A, 6+4 Lead ECG Trunk AAMI/IEC 2.7m; M1671A, 3 Leadset, Grabber, AAMI, ICU; M1673A, 3 Leadset, Sn | Philips Medizin Systeme Böblingen GmbH | 2025-01-17 | Traditional | PDF ↗ |
| K240087 | RT Carbon ECG Leads | Ivy Biomedical Systems, Inc. | 2024-09-13 | Traditional | PDF ↗ |
| K240377 | LIFEPAK® ECG Cables | Stryker Physio-Control | 2024-05-07 | Traditional | PDF ↗ |
| K240156 | LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021); LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024) | Physio-Control, Inc. | 2024-04-30 | Traditional | PDF ↗ |
| K222712 | Fogg System Patient Monitoring Cables | Fogg System Company, Inc. | 2023-11-22 | Traditional | PDF ↗ |
| K230571 | RFP-100A Connector Cable (Single Use) | Baylis Medical Technologies, Inc. | 2023-05-30 | Traditional | PDF ↗ |
| K222370 | SpO2 Extension Cable | Beijing Rongrui-Century Science & Technology Co., Ltd. | 2023-04-02 | Traditional | PDF ↗ |
| K220447 | Med-link Disposable ECG Cable and Leadwires | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2022-06-28 | Traditional | PDF ↗ |
| K211941 | 9Line | Energetic Designs, Inc. | 2022-01-27 | Traditional | PDF ↗ |
| K211294 | Multi-Link X2 ECG Cable and Leadwire System | Vyaire Medical, Inc. | 2021-08-16 | Traditional | PDF ↗ |
| K203556 | Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables | Medtronic, Inc. | 2021-07-12 | Traditional | PDF ↗ |
| K200722 | PCA-C1 series Patient Cable | QT Medical, Inc. | 2021-06-03 | Traditional | PDF ↗ |
| K203635 | Patient Monitoring Cables | Jkh USA, LLC | 2021-02-05 | Traditional | PDF ↗ |
| K200510 | Multi-LinkTM X2 ECG Adapter and Leadwires | Vyaire Medical, Inc. | 2020-10-09 | Traditional | PDF ↗ |
| K201359 | ECG Cables and Leadwires | Xinkang Medical Instrument Co. , Ltd. | 2020-10-01 | Traditional | PDF ↗ |
| K200674 | AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector | Atrility Medical, LLC | 2020-07-02 | Abbreviated | PDF ↗ |
| K192404 | Patient Monitoring Cable (SpO2 Extension Cable) | Shenzhen Coreray Technology, Ltd. | 2020-06-22 | Traditional | PDF ↗ |
| K200026 | Disposable ECG Cable | Shenzhen Changke Connect Electronics Co., Ltd. | 2020-05-12 | Traditional | PDF ↗ |
| K181089 | SureLead Cable System | Authentic Medical | 2020-01-17 | Traditional | PDF ↗ |
| K191428 | ECG Cable | Shenzhen Changke Connect Electronics Co., Ltd. | 2019-11-27 | Traditional | PDF ↗ |
| K191273 | Multi-Link X2 ECG and SpO2 Adapter | Vyaire Medical, Inc. | 2019-09-13 | Traditional | PDF ↗ |
| K190078 | IntraSight | Volcano Corporation | 2019-02-11 | Special | PDF ↗ |
| K182327 | Patient Cables and Leadwires , Disposable ECG Leadwires | Orantech, Inc. | 2019-01-30 | Traditional | PDF ↗ |
| K182220 | Curbell branded Patient Monitoring Cables | Curbell Medical Products, Inc. | 2018-11-07 | Special | PDF ↗ |
| K181726 | Medline Patient Cables and Lead Wires | Medline Industries, Inc. | 2018-09-20 | Traditional | PDF ↗ |
| K172797 | ECG Cable/Leadwires | Shenzhen Coreray Technology, Ltd. | 2018-02-28 | Traditional | PDF ↗ |
| K172591 | Fixed Patient Leads ECG Cable (Model 3153) | Boston Scientific Corporation | 2017-11-03 | Special | PDF ↗ |
| K162768 | ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables | Integral Process Sas | 2017-08-16 | Abbreviated | PDF ↗ |
| K163316 | Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System | Carefusion 303, Inc. | 2017-06-22 | Traditional | PDF ↗ |
| K170536 | ECG Disposable Lead Wire | APK Technology Co., Ltd. | 2017-04-24 | Traditional | PDF ↗ |
| K162432 | Multi-Link X2 ECG Cable and Lead Wire System | Carefusion 2200, Inc. | 2017-01-18 | Traditional | PDF ↗ |
| K153188 | Caremed patient cable and leadwires | Shenzhen Caremed Medical Technology Co., Ltd. | 2016-10-24 | Traditional | PDF ↗ |
| K152947 | Disposable Temporary Pacing Cable | Tiger Medical Products | 2016-04-05 | Traditional | PDF ↗ |
| K142489 | Unimed Disposable ECG lead wires | Unimed Medical Supplies, Inc. | 2014-11-04 | Traditional | PDF ↗ |
| K132253 | REMOVABLE PATIENT LEADS ECG CABLE | Boston Scientific | 2013-12-16 | Traditional | PDF ↗ |
| K120010 | CABLE/ LEAD-WIRE (ECG, EKG, SPO2 AND INVASIVE BLOOD PRESSURE) | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2012-01-19 | Traditional | PDF ↗ |
| K110287 | PHILIPS ECG LEADWIRE SET | Philips Medical Systems | 2011-02-15 | Abbreviated | PDF ↗ |
| K102430 | TYCO ELECTRONICS ELECTROCARDIOGRAPH (ECG) LEADWIRE SET | Tyco Electronics Corporation | 2010-09-10 | Traditional | PDF ↗ |
| K101660 | ECG SINGLE PATIENT USE LEAD WIRE SET, MODELS 2048801-5 TO 2048801-8 | Kepler Medtec | 2010-08-11 | Traditional | PDF ↗ |
| K093858 | PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A | St. Jude Medical, Cardiac Rhythm Management Divisi | 2010-04-02 | Traditional | PDF ↗ |
| K093657 | ADAGIO RETRACTING ECG LEAD WIRES | Acist Medical Systems, Inc. | 2010-01-15 | Traditional | PDF ↗ |
| K082851 | MULTLINK CABLE AND LEADWIRE SYSTEM | Ge Medical Systems Information Technologies | 2008-11-19 | Traditional | PDF ↗ |
| K082959 | PATIENT MONITORING CABLES FOR ECG, EKG, SPO2 AND BLOOD PRESSURE MONITORS | Unimed Medical Supplies, Inc. | 2008-10-10 | Traditional | PDF ↗ |
| K081762 | CURBELL PATIENT MONITORING CABLES | Curbell Electronics, Inc. | 2008-08-27 | Abbreviated | PDF ↗ |
| K080112 | PATIENT CABLE | Med-Dyne | 2008-06-20 | Traditional | PDF ↗ |
| K080605 | SURE-LOCK ELECTRODE CLIP, MODEL CL-34, CL-A60, CL-HW, CL-TL | Curbell Electronics, Inc. | 2008-05-05 | Special | PDF ↗ |
| K080621 | FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01 | European Custom Manufacturing BV | 2008-04-29 | Traditional | PDF ↗ |
| K071751 | LIFESYNC ADAPTER, MODEL LS-302 | Lifesync Corporation | 2007-08-27 | Abbreviated | PDF ↗ |
| K070232 | ECG CABLES, TRUNK AND PATIENT LEAD WIRES | American I.V. Products, Inc. | 2007-03-27 | Abbreviated | PDF ↗ |
| K062577 | V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC | Tz Medical, Inc. | 2006-12-15 | Traditional | PDF ↗ |
| K043572 | COMPATIBILITY ECG TRUNK CABLES | Datex-Ohmeda | 2005-02-22 | Traditional | PDF ↗ |
| K030005 | VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER ACCESSORY CABLES | Vanguard Medical Concepts, Inc. | 2003-03-18 | Traditional | PDF ↗ |
| K023334 | BMC CATHETER CONNECTOR CABLE, MODEL RFP-101 | Baylis Medical Co., Inc. | 2002-12-31 | Traditional | PDF ↗ |
| K022075 | DISPOSABLE TEMPORARY PACING CABLE,MODELS CPW-BV-5,CPW-LG-5,CPW-SM-5,CPW-ERA300-5,CPW-QLOC-5 | Cp Medical | 2002-09-19 | Traditional | PDF ↗ |
| K013598 | REUSE CLAIM FOR THE BARD ELECTROPHYSIOLOGY SURELINK, TEMPLINK, AND TEMPLINK M EXTENSION CABLES | C.R. Bard, Inc. | 2002-01-11 | Traditional | PDF ↗ |
| K012392 | DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260 | Pace Medical | 2001-09-04 | Traditional | PDF ↗ |
| K010809 | BIOCONNECT PATIENT MONITORING CABLES AND LEADWIRES, CAT# 1000 THRU CAT# 40000 | Rf Industries, Ltd. | 2001-05-23 | Traditional | PDF ↗ |
| K002781 | MEDICAL CABLES PATIENT MONITORING CABLES FOR ECG, EEG, SPO2, AND BLOOD PRESSURE MONITORS | Medical Cables, Inc. | 2000-11-29 | Abbreviated | PDF ↗ |
| K001390 | BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES | Biosense Webster, Inc. | 2000-07-21 | Abbreviated | PDF ↗ |
| K992524 | PATIENT CABLES FOR MONITORING, I.E., ECG, EKG, SPO2, AND BP INTERFACE CABLES AND LEADWIRES | Advantage Medical Electronics, Inc. | 2000-03-01 | Traditional | PDF ↗ |
| K984263 | EWC: ECG II CABLE LEADWIRE SYSTEM | Ewc | 1999-02-02 | Abbreviated | PDF ↗ |
| K982817 | EWC: ECG CABLE AND LEADWIRE SYSTEMS | Ewc | 1998-09-23 | Traditional | PDF ↗ |
| K980806 | AFFINITY MEDICAL PATIENT CABLE SYSTEM | Affinity Medical Technologies, LLC | 1998-03-25 | Traditional | PDF ↗ |
| K980582 | MULTI-LINK CABLE AND LEAD WIRE SYSTEMS | Marquette Medical Systems, Inc. | 1998-03-16 | Traditional | PDF ↗ |
| K971968 | SAFE CONNECT SURGICAL CABLE (S-101-97/S-201-97/FL-601-97) | Remington Medical, Inc. | 1997-07-23 | Traditional | PDF ↗ |
| K954900 | 3M RED DOT ECG LEAD WIRES A | Minnesota Mining and Mfg. Co. | 1996-07-15 | Traditional | PDF ↗ |
| K960446 | MODEL 5471 & 5471L STERILE DISPOSABLE PATIENT CABLE ASSEMBLIES | Medtronic Vascular | 1996-05-22 | Traditional | PDF ↗ |
| K952659 | TRONOMATE PATIENT CABLE & LEADWIRE SYSTEM | Tronomed, Inc. | 1996-01-11 | Traditional | PDF ↗ |
| K940323 | ARBO DIAGNOSTIC ECG PATIENT CABLES & LEADWIRES ARBO SHIELDED MULTI-LEAD CABLE & LEAD SYSTEM | Arbo Medical, Inc. | 1995-04-12 | Traditional | PDF ↗ |
| K940302 | ARBO MONITRING SAFETY CABLE & LEAD WIRE SYSTEMS/ARBO UNSHEILDED SAFETY CABLE & LEAD SYSTEM | Arbo Medical, Inc. | 1994-11-30 | Traditional | PDF ↗ |
| K940322 | ARBO VS MONITOR CABLE & LEADWIRE SYSTEM ARBO SHIELDED SAFETY CABLE & LEAD WIRE | Arbo Medical, Inc. | 1994-11-28 | Traditional | PDF ↗ |
| K942321 | VARIOUSPATIENT MONITORING CABLE | Merit Cables Incorporated | 1994-11-04 | Traditional | PDF ↗ |
| K945034 | CONMED ECG PATIENT SAFETY CABLES AND LEADWIRES-REMOVAL AND PERMANENTLY-ATTACHED LEADWIRES | Conmedcorp | 1994-10-27 | Traditional | PDF ↗ |
| K941839 | DISPOSABLE SURGICAL CABLE | Conmed Andover Medical, Inc. | 1994-07-27 | Traditional | PDF ↗ |
| K941058 | PROCATH PACING THRESHOLD CABLE | Professional Catheter Corp. | 1994-07-11 | Traditional | PDF ↗ |
| K933649 | CONMED ECG PATIENT CABLES AND LEADWIRES | Conmedcorp | 1994-02-18 | Traditional | PDF ↗ |
| K933603 | LEADWIRE | Sentry Medical Products, Inc. | 1994-01-18 | Traditional | PDF ↗ |
| K932704 | PATIENT CABLE | Sentry Medical Products, Inc. | 1993-12-27 | Traditional | PDF ↗ |
| K922009 | DISPOSABLE SURGICAL EXTENSION CABLE MODEL S-101 | Remington Medical, Inc. | 1993-02-25 | Traditional | PDF ↗ |
| K922899 | MODEL 4280 SURGICAL EXTENSION CABLE | Pace Medical | 1992-12-23 | Traditional | PDF ↗ |
| K910645 | DISPOSABLE PATIENT CABLE | Diag Corp. | 1991-05-07 | Traditional | PDF ↗ |
| K901780 | RTM 36-05, 60-05, RTD 36-05, 60-05 RADIO. LEADWIRE | Medtronic Vascular | 1990-10-09 | Traditional | PDF ↗ |
| K894981 | MEDTRONIC MODEL 5455S DISPOSABLE SURGICAL CABLE | Medtronic Vascular | 1989-09-20 | Traditional | PDF ↗ |
| K885137 | ASTRO TRACE (MODEL AT-02) | The LE Blanc Corp. | 1989-03-15 | Traditional | PDF ↗ |
| K884592 | ASTRO TRACE (MODEL AT-01) | The LE Blanc Corp. | 1989-03-02 | Traditional | PDF ↗ |
| K885101 | MEDTRONIC MODEL 5411B SURGICAL CABLE ADAPTOR | Medtronic Vascular | 1989-01-12 | Traditional | PDF ↗ |
| K882174 | MODIFIED MODEL 5455 DISPOSABLE SURGICAL CABLE | Medtronic Andover Medical, Inc. | 1988-07-22 | Traditional | PDF ↗ |
| K880320 | ELECTRODE CABLE | Vital Connections, Inc. | 1988-03-22 | Traditional | PDF ↗ |
| K880323 | MEDTRONIC MODEL 5411 SURGICAL CABLE ADAPTOR | Medtronic Vascular | 1988-03-22 | Traditional | PDF ↗ |
| K873492 | BSK-1033 TELEMETRY MONITORING CABLE | Desco Industries, Inc. | 1987-10-09 | Traditional | PDF ↗ |
| K820268 | ADAPTAID TEMP. PACING EXT. LEAD #366-02 | Intermedics, Inc. | 1982-03-26 | Traditional | PDF ↗ |
| K802237 | CORROSION PROOF DUAL PURPOSE ECG WIRES | Custom Cardio Components | 1980-10-03 | Traditional | PDF ↗ |
| K802236 | CORROSION PROOF SNAP ECG CONNECT WIRES | Custom Cardio Components | 1980-10-03 | Traditional | PDF ↗ |
| K800932 | ECG-RF-CHOKE CABLE-ADAPTER #'S 121,120 | R2 Corp. | 1980-05-23 | Traditional | PDF ↗ |
| K800931 | R2(TM) ECG CABLE-ADAPTOR #'S 120-121-122 | R2 Corp. | 1980-05-23 | Traditional | PDF ↗ |
| K801041 | 3M R.F. CURRENT SUPPRESSOR | 3M Company | 1980-05-23 | Traditional | PDF ↗ |
Product code DSA · Class II · Cardiovascular. Data: openFDA.