meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
43
Latest Decision
1993-10-07

Clearances · page 126 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K923344 ELECTRONIC DIGITAL BLOOD PRESSURE MONITOR Citizen Watch Co., Ltd. DXN Class II 1993-10-07
K934122 SCIMED TRANSEND EX STEERABLE GUIDE WIRE AND ACCESSORIES Scimed Peripheral Interventions DQX Class II 1993-10-07
K931479 SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER Mallinckrodt Medical DQO Class II 1993-10-06
K933975 MEADOX SURGIMED DISPOSABLE PRESSURE GUAGE FOR USE WITH THE OLBERT CATHETER SYSTEM Meadox Medicals, Div. Boston Scientific Corp. LIT Class II 1993-10-06
K931587 MULTI-PORT Y INTRODUCER SET Thomas Medical Products, Inc. DYB Class II 1993-10-06
K931296 PACEART CARDIOPHONE Paceart, Inc. DXH Class II 1993-10-01
K933466 USCI MACH 10 GUIDE WIRE WITH PRO/PEL COATING C.R. Bard, Inc. DQX Class II 1993-10-01
K923947 MEADOX SURGIMED BALLOON CATHETER Meadox Medicals, Div. Boston Scientific Corp. LIT Class II 1993-09-30
K920077 NIKKISO NK PUMP International Medical Products, Inc. DWD Class II 1993-09-29
K933019 USCI SUPER 6 6F PTCA GUIDING CATHETER C.R. Bard, Inc. DQY Class II 1993-09-28
K931833 MODIFIED LUER Medi-Dyne, Inc. DQO Class II 1993-09-28
K931586 VITAL-PORT MINI VASCULAR ACCESS SYSTEM Med Institute, Inc. DWF Class II 1993-09-27
K925248 MODIFICATION OF INTRA-AORTIC BALLOON CATHETERS Kontron Instruments, Inc. DSP Class II 1993-09-27
K933483 OPTI-PLAST 5F PTA CATHETERS Vas-Cath, Inc. LIT Class II 1993-09-24
K925439 MICROSNARE Microvena Corp. DQY Class II 1993-09-24
K921666 CARDIAC THERAPHY SYSTEM SCP 900 Ppg Hellige B.V. LDD Class II 1993-09-23
K931411 MEDTRONIC MODEL 4081,4581,4582 TARGET TIP PACING L Medtronic Vascular DTB Class III 1993-09-23
K930801 INTROPEEL Menlo Care, Inc. DYB Class II 1993-09-22
K931218 INTROPEEL V Menlo Care, Inc. DYB Class II 1993-09-22
K930194 HEMOSTASIS VALVE AND TUBING SET Opticon Medical, Inc. DYB Class II 1993-09-22
K923406 BIOSCOPE Biotronik, GmbH & Co. DPS Class II 1993-09-22
K930639 ON-LINE ANALYSIS SYSTEM Softheart, Inc. DQK Class II 1993-09-22
K932009 THE SAMUELS RETROGRAD VALVULOTOME Vascutech, Inc. MGZ Class II 1993-09-21
K925402 OSCILLOMATE BLOOD PRESSURE MONITOR-MODEL 9300 Cas Medical Systems, Inc. DXN Class II 1993-09-17
K931384 AVE ALLIANCE DILATATION CATHETER Applied Vascular Engineering, Inc. LIT Class II 1993-09-17
K930227 MS DISPOSABLE RIGID DOPPLER PROBE Meadox Medicals, Div. Boston Scientific Corp. DPW Class II 1993-09-16
K933259 SCD(R) CONTROLLER Kendall Healthcare Products Co. Div.Of Tyco Health JOW Class II 1993-09-13
K924752 FREEDOM OXIMETER/EEG DIGITAL INTERFACE Pro-Tech, Inc. DQA Class II 1993-09-10
K933033 GUIDING CATHETER HEMOSTASIS VALVE CAP Arrow Intl., Inc. DQY Class II 1993-09-10
K933183 SCIMED VIPER Scimed Life Systems, Inc. LIT Class II 1993-09-09
K932929 HRV 4000EM All-Tronics Medical Systems DSH Class II 1993-09-09
K915547 SARNS 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT 3M Health Care, Sarns KFM Class II 1993-09-09
K930095 SPACELABS MEDICAL PATIENT MONITOR Spacelabs Medical, Inc. DSI Class II 1993-09-03
K924163 EXPLORER/360-POLARIS-L.E./JACKMAN CORON SINUS ELEC Boston Scientific Corp DRF Class II 1993-09-03
K922799 CAPIOX SX HOLLOW FIBER OXYGENATOR Terumo Medical Corp. DTZ Class II 1993-09-02
K930312 3M RED DOT 2234 RADIOLUCENT MONITORING ELECTRODE 3M Health Care, Ltd. DRX Class II 1993-09-01
K932801 CARDIMA SEEKER AND STUBBIE GUIDEWIRES Cardima, Inc. DQX Class II 1993-09-01
K932788 CORDIS BIPAL 7 BIOPSY FORCEPS WITH A INLINE HANDLE Cordis Corp. DWZ Class II 1993-09-01
K931662 LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES Pace Medical DYB Class II 1993-08-31
K932921 PERCUTANEOUS INTRODUCER FOR VENA CAVA FILTER SYST B. Braun Vena-Tech DTK Class II 1993-08-30
K926000 9.5 FR SIDEWINDER DL INTRA-AORTIC BALLON CATHETER Boston Scientific Corp DSP Class II 1993-08-30
K932218 CARDIAC CATH OR ANGIOGRAPHIC TRAYS Associated Medical Products Co. DQO Class II 1993-08-27
K932733 CORDIS CATHETER SHEATH INTRODUCER Cordis Corp. DYB Class II 1993-08-26
K924390 ANGEMED 5000 LEAD ADAPTER Angemed, Inc. LDF Class II 1993-08-25
K914802 DATASCOPE PERCOR STAT DL9.5 FR34CC INTRA-AORT BALL Datascope Corp. DSP Class II 1993-08-25
K911000 PERCOR STAT DL 8.5 FR 40CC INTRA-AORTIC BALLOON Datascope Corp. DSP Class II 1993-08-25
K913831 VASCO TIP/VASCOFLANGE Vascor Medical Corp. DTB Class III 1993-08-25
K933238 ROTABLATOR, MODIFICATION Heart Technology, Inc. MCW Class II 1993-08-24
K932619 TRANSSEPTAL INTRODUCER SET Thomas Medical Products, Inc. DQY Class II 1993-08-24
K914121 VASCOSCREW 6/60 AND VASCOSCREW 8/60 Vascor Medical Corp. DTB Class III 1993-08-24
K926413 MEDTRONIC ARTERIAL FILTER Medtronic Vascular DTM Class II 1993-08-24
K925524 CARDIOMETRICS SMARTWIRE(TM)/FLOMAP(R) Cardio Metrics, Inc. DPW Class II 1993-08-23
K924737 INNERSENSE(TM) DISPOSABLE MICROTRANSDUCER Becton Dickinson Vascular Access, Inc. DXO Class II 1993-08-23
K925947 B-D ARTERIAL BLOOD CONTAINMENT DEVICE Bd Becton Dickinson Vacutainer Systems Preanalytic DQX Class II 1993-08-20
K923026 PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER Biotronik, GmbH & Co. DXY Class III 1993-08-19
K924558 ARROW BLOOD CONTAINMENT DEVICE Arrow Intl., Inc. DQX Class II 1993-08-19
K932420 SCIMED 6 FR., 7 FR., AND 8 FR.,TRIGUIDE GUIDING Scimed Life Systems, Inc. DQO Class II 1993-08-17
K932454 3M RED DOT 2330 RESTING EKG ELECTRODE 3M Health Care, Ltd. DRX Class II 1993-08-16
K926243 ANGIOGRAPHIC CATHETER Target Therapeutics DQO Class II 1993-08-16
K924385 NEW HYDROPHILIC COATING FOR WIRE GUIDES Arrow Intl., Inc. DQX Class II 1993-08-15
K932542 SCIMED 6F ANGIOGRAPHIC CATHETER Scimed Life Systems, Inc. DQO Class II 1993-08-11
K926099 DATASCOPE 6000 MONITOR Datascope Corp. MLC Class II 1993-08-06
K930057 ANGESTAT FLUORO-TIP HEMOSTASIS INTRODUCER SET B.Braun Medical, Inc. DYB Class II 1993-08-06
K930345 TC2000 POWER UNIT AND ACCESSORIES Gaymar Industries, Inc. DWJ Class II 1993-08-06
K932835 KENDALL T.E.D./SCD SEQUENTIAL COMPRESSION DEVICE Kendall Healthcare Products Co. Div.Of Tyco Health JOW Class II 1993-08-06
K932251 ROTATOR;MALE-MALE, MALE-FEMALE Merit Medical Systems, Inc. DTR Class II 1993-08-05
K932254 MAXIMA FILTERED HARDSHELL RESERVOIR Medtronic Vascular DTB Class III 1993-08-03
K920427 PERCOR STAT DL 9.5 FR 40CC INTRA-AORTIC BALLOON Datascope Corp. DSP Class II 1993-08-03
K905663 PEDIATRIC INTRA-AORTIC BALLOON CATHETERS Datascope Corp. DSP Class II 1993-08-02
K930694 MEDI-DYNE ANGIOGRAPHIC CATHETER Medi-Dyne, Inc. DQO Class II 1993-08-02
K925744 TEMPA-KUFF SINGLE PAT PRE-GAGED BALANCED DISP CUFF Pymah Corp. DXQ Class II 1993-07-30
K924544 CARDIAX Fairlake Marketing Group, Inc. DPS Class II 1993-07-29
K932092 USCI ANGIOGRAPHIC CATHETER C.R. Bard, Inc. DQO Class II 1993-07-29
K915363 SARNS 7850 CENTRIFUGAL PUMP (MODIFIED) 3M Health Care, Ltd. KFM Class II 1993-07-28
K931403 SITERITE NEEDLE GUIDE (MODIFIED) Dymax Corp DQY Class II 1993-07-27
K930888 WRISTRECORDER PLUS CARDIAC EVENT RECORDING SYSTEM Ralin Medical, Inc. DRS Class II 1993-07-21
K930232 CVIS INSIGHT IMAGING GUIDE CATHETER Cardiovascular Imaging Systems, Inc. DQO Class II 1993-07-21
K925285 DUALTHERM(R) CARDIAC OUTPUT COMPUTER B. Braun of America, Inc. DQK Class II 1993-07-21
K932215 COWBOY III Kinetic Concepts, Inc. JOW Class II 1993-07-21
K923747 CC ARHYTHMIS MONITORING OPTION Hewlett-Packard Co. DSI Class II 1993-07-20
K920429 MODIFIED MODEL M1403A TELEMETRY MONITORING SYSTEM Hewlett-Packard Co. MLD Class II 1993-07-20
K925444 CARDIAC OUTPUT PULMONARY ARTERY CATHETER & MONITOR Ami-Med Corp. DYG Class II 1993-07-19
K920966 SDI OXYGEN/DIGITAL OXYGEN TRANSDUCERS (DOT) Aristo Medical Products, Inc. DQA Class II 1993-07-16
K931327 PSG DIRECTIONAL HYDROPHILIC GUIDE WIRE Peripheral Systems Group DQX Class II 1993-07-14
K931967 HE-30 GOLD Bentley Laboratories, Inc. DTR Class II 1993-07-13
K923104 TROPIC-AIR Seabrook Medical Systems, Inc. DWJ Class II 1993-07-13
K923231 CARDIO-PAK BASIC PUMP PACK Cardio-Med-Associates, Inc. DWE Class II 1993-07-09
K930787 LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER KIT Advanced Surgical, Inc. DQX Class II 1993-07-09
K924208 BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P) Medtronic Bio-Medicus, Inc. DPT Class II 1993-07-08
K923595 SYSTEM 7110 NON-INVASIVE BLOOD PRESSURE MONITOR Advanced Medical Instruments, Inc. DXN Class II 1993-07-01
K921048 BP8800T/8000IR/8300G NON-INVASIVE BLOOD PRES. SYST Colin Medical Instruments Corp. DXN Class II 1993-07-01
K930154 EL2-SERIES BLOOD COLLECTION REERVOIR Electromedics, Inc. DTN Class II 1993-07-01
K915697 CRITIKON VITAL SIGNS MODULE Critikon Company, LLC DXN Class II 1993-07-01
K931584 SCIMED TRANSPORT STEERABLE GUIDE WIRE AND ACCESS. Scimed DQX Class II 1993-07-01
K924922 CVIS INSIGHT IMAGING CATHETER Cardiovascular Imaging Systems, Inc. DQO Class II 1993-06-29
K921247 ZEPHYR INFUSION CATHETER Target Therapeutics KRA Class II 1993-06-29
K924227 CRI CYNOSAR CATHETER Catheter Research C/O Burditt, Bowles & Radzius DRA Class II 1993-06-29
K925632 BALT GUIDING CATHETER Target Therapeutics DQO Class II 1993-06-29
K930548 DPD DEFIBRILLATOR Medical Research Laboratories, Inc. LDD Class II 1993-06-25
K925633 BALT INTRODUCER Target Therapeutics DYB Class II 1993-06-25

19,212 clearances in the Cardiovascular panel. Data: openFDA.