FDA Product Code
FDA Product Code DTB — Clearance Directory
- Device Class
- Class III
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.3680
510(k) Clearances — 487 records · page 2 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K903928 | LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UP | Biotronik, GmbH & Co. | 1990-10-16 | Traditional | PDF ↗ |
| K903927 | LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 45-UP | Biotronik, GmbH & Co. | 1990-10-16 | Traditional | PDF ↗ |
| K902002 | MODELS 5069/5071 MYOCARDIAL PACING LEADS | Medtronic Vascular | 1990-09-26 | Traditional | PDF ↗ |
| K896824 | BIOTRONIK'S PS-ENDOCARDIAL LEADS | Biotronik, GmbH & Co. | 1990-08-08 | Traditional | PDF ↗ |
| K900645 | LASERDISH POLYURETHANE VENTRICULAR LEAD W/TRAILING | Telectronics Pacing Systems, Inc. | 1990-08-08 | Traditional | PDF ↗ |
| K896742 | FOCUS J81F, J83F, J41F, J43F PACING LEADS | Ela Medical, Inc. | 1990-07-17 | Traditional | PDF ↗ |
| K902147 | ENDOCARDIAL SCREW-IN LEAD MODEL 1028T | Pacesetter Systems | 1990-07-17 | Traditional | PDF ↗ |
| K901402 | VS-1 LEAD EXT. 033-302, 4.75MM 033-260, 033-458 | Telectronics Pacing Systems, Inc. | 1990-06-12 | Traditional | PDF ↗ |
| K901709 | DNP 60-B UNIPOLAR ENDOCARDIAL LEAD | Biotronik, GmbH & Co. | 1990-05-22 | Traditional | PDF ↗ |
| K900984 | MODIFIED UNIPOLAR IMPLANT. PACING LEADS W/IS-1 | Medtronic Vascular | 1990-05-03 | Traditional | PDF ↗ |
| K900550 | FAST-PASS ACE MODELS 1212T/1222T/1216T/1226T | Pacesetter Systems | 1990-04-20 | Traditional | PDF ↗ |
| K896313 | MEDTRONIC IMPLANTABLE PACING LEADS W/IS-1 CONN. | Medtronic Vascular | 1990-03-06 | Traditional | PDF ↗ |
| K895136 | PERMANENT AND TEMP. PACEMAKER ELECTRODE & LEAD ADA | Medtronic Vascular | 1990-02-08 | Traditional | PDF ↗ |
| K897067 | MODIFIED J-STIFFENER WIRE MATERIAL IN LEAD LINES | Telectronics Pacing Systems, Inc. | 1990-02-05 | Traditional | PDF ↗ |
| K892528 | FIVE-YEAR STERILE PACKAGING SHELF LIFE | Daig Corp. | 1990-01-18 | Traditional | PDF ↗ |
| K895447 | ENDOCARDIAL SCREW-IN LEAD MODEL 1020T | Pacesetter Systems | 1989-12-20 | Traditional | PDF ↗ |
| K896443 | MYOPORE(TM) UNIPOLAR MODELS 1117 & 1118 PACE LEADS | Possis Medical, Inc. | 1989-12-20 | Traditional | PDF ↗ |
| K893041 | NEW ADHESIVE, PELLETHAN ON POLYURETHANE LEADS-MODI | Telectronics Pacing Systems, Inc. | 1989-11-14 | Traditional | PDF ↗ |
| K885175 | MYOPORE(TM) UNIPOLAR SUTURELESS MYOCARDIAL LEADS | Possis Medical, Inc. | 1989-07-14 | Traditional | PDF ↗ |
| K894040 | IMPLANTABLE PACING LEADS W/IS-1 CONN., UNIPOLAR | Medtronic Vascular | 1989-07-14 | Traditional | PDF ↗ |
| K893763 | MODELS 1113 AND 1114 PACEMAKER LEADS | Possis Medical, Inc. | 1989-07-14 | Traditional | PDF ↗ |
| K890018 | PACEMAKER LEAD ADAPTER | Ela Medical, Inc. | 1989-06-20 | Traditional | PDF ↗ |
| K891905 | CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE | Pacesetter Systems | 1989-06-05 | Traditional | PDF ↗ |
| K890644 | MEDTRONIC MODEL 5866-45 SIZING SLEEVE | Medtronic Vascular | 1989-05-31 | Traditional | PDF ↗ |
| K890527 | ALTERNATE PACKAGING CONFIGURATION FOR PACING LEADS | Medtronic Vascular | 1989-04-21 | Traditional | PDF ↗ |
| K884697 | HEPARIN BONDING FOR CATHETERS | Daig Corp. | 1989-04-19 | Traditional | PDF ↗ |
| K890411 | MODELS 432-03 & 433-03 IMPLANTABLE PACING LEADS | Intermedics, Inc. | 1989-03-28 | Traditional | PDF ↗ |
| K890412 | MODELS 430-07 & 431-07 IMPLANTABLE PACING LEADS | Intermedics, Inc. | 1989-03-28 | Traditional | PDF ↗ |
| K890547 | SIEMENS ELEMA MODELS 4025 AND 4026 ADAPTERS | Pacesetter Systems | 1989-03-22 | Traditional | PDF ↗ |
| K884811 | ACCUFIX AND LASERDISH BIPOLAR VS-1 LEADS | Telectronics and Control Pacing Systems | 1989-02-22 | Traditional | PDF ↗ |
| K885240 | MODIFIED ANCOR & HI-FLEX UNIPOLAR ACTIVE FIX. LEAD | Tpl-Cordis, Inc. | 1989-02-10 | Traditional | PDF ↗ |
| K890350 | VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE) | Telectronics, Inc. | 1989-02-02 | Traditional | PDF ↗ |
| K890045 | MODEL 6208,6209,6210,6211,6212,6214 (PLI'S) | Medtronic Vascular | 1989-01-30 | Traditional | PDF ↗ |
| K883743 | MEDTRONIC MODEL 4058 PACING LEAD | Medtronic Vascular | 1989-01-17 | Traditional | PDF ↗ |
| K884278 | IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436 | Telectronics, Inc. | 1988-12-15 | Traditional | PDF ↗ |
| K884394 | PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F | Ela Medical, Inc. | 1988-12-08 | Traditional | PDF ↗ |
| K883070 | ENCOR UNIPOLAR VS-1 LEADS | Cordis Leads, Inc. | 1988-12-05 | Traditional | PDF ↗ |
| K884005 | ENDOCARDIAL PACING LEADS-ANCHORING SLEEVE MODIFIED | Medtronic Vascular | 1988-12-05 | Traditional | PDF ↗ |
| K882462 | PERMANENT PACING LEAD MODEL RXBJ SERIES | Oscor Medical Corp. | 1988-10-28 | Traditional | PDF ↗ |
| K882345 | PERMANENT PACING LEADS PYBJ SERIES | Oscor Medical Corp. | 1988-10-28 | Traditional | PDF ↗ |
| K873772 | CHANGES TO ENCOR PERVENOUS J-ATRIAL LEADS | Cordis Leads, Inc. | 1988-10-19 | Traditional | PDF ↗ |
| K883265 | MODEL 329-701 BIPOLAR ACTIVE-FIXATION LEAD | Telectronics and Cordis Pacing Systems | 1988-10-14 | Traditional | PDF ↗ |
| K884024 | POLYSAFE(TM) IMPLANTABLE PACING LEAD | Cardiac Control Systems, Inc. | 1988-10-14 | Traditional | PDF ↗ |
| K881810 | MEDTRONIC MODEL 4951P | Medtronic Vascular | 1988-10-13 | Traditional | PDF ↗ |
| K883015 | POLYSAFE IMPLANT. PACING LEADS W/TRABECULOK TIP | Cardiac Control Systems, Inc. | 1988-10-06 | Traditional | PDF ↗ |
| K883016 | POLYSAFE IMPLANT. PACING LEADS W/TINED FIXA. TIP | Cardiac Control Systems, Inc. | 1988-09-16 | Traditional | PDF ↗ |
| K883602 | BIOPORE VS.1 ENDOCARDIAL INTER IMPLANT PACING LEAD | Intermedics, Inc. | 1988-09-06 | Traditional | PDF ↗ |
| K883203 | MODEL 5866-34A PACEMAKER LEAD ADAPTOR | Medtronic Vascular | 1988-09-06 | Traditional | PDF ↗ |
| K882452 | MEDTRONIC MODELS 4057/4557 ENDOCARDIAL PACING LEAD | Medtronic Vascular | 1988-08-25 | Traditional | PDF ↗ |
| K874366 | ENCOR BIPOLAR ACT/FIXA LEAD W/POR SUR ELE #329-201 | Cordis Leads, Inc. | 1988-06-16 | Traditional | PDF ↗ |
| K874664 | IMPLANTABLE ELECTRODE LEAD, MODEL 030-446 | Telectronics, Inc. | 1988-05-31 | Traditional | PDF ↗ |
| K875178 | MODEL 435-04 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD | Intermedics, Inc. | 1988-05-25 | Traditional | PDF ↗ |
| K881712 | MEDTRONIC MODEL 5866-36 LEAD ADAPTOR KIT | Medtronic Vascular | 1988-05-25 | Traditional | PDF ↗ |
| K875100 | MODEL 438-03 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD | Intermedics, Inc. | 1988-05-24 | Traditional | PDF ↗ |
| K872126 | MODEL 438-02 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD | Intermedics, Inc. | 1988-03-22 | Traditional | PDF ↗ |
| K880551 | MODEL 439-07 AND 439-09 LIFELINE MYOCARDIAL LEAD | Intermedics, Inc. | 1988-03-07 | Traditional | PDF ↗ |
| K875199 | NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTOR | Biotronik Sales, Inc. | 1988-02-18 | Traditional | PDF ↗ |
| K872971 | PERMANENT MYOCARDIAL LEADS MP SERIES | Oscor Medical Corp. | 1988-02-12 | Traditional | PDF ↗ |
| K873962 | MEDTRONIC MODEL 4016A ENDOCARDIAL PACING LEAD | Medtronic Vascular | 1988-02-02 | Traditional | PDF ↗ |
| K874205 | ENDOCARDIAL SCREW-IN LEAD, MODEL 1018T | Pacesetter Systems | 1988-02-02 | Traditional | PDF ↗ |
| K874183 | ACTIFIX (R) BIPOLAR ENDOCARDIAL SCREW-IN LEAD | Daig Corp. | 1988-01-29 | Traditional | PDF ↗ |
| K874792 | MODEL 5013 TRANSVENOUS VENTRICULAR PACING LEAD | Medtronic Vascular | 1988-01-19 | Traditional | PDF ↗ |
| K874743 | PACING LEADS MODEL 3262VU/VB, 3362VU/VB, 3380/3390 | Pace Medical | 1988-01-19 | Traditional | PDF ↗ |
| K874531 | POLYFLEX(R) EPICARDIAL 439-04 IMPLANT PACING LEAD | Intermedics, Inc. | 1988-01-07 | Traditional | PDF ↗ |
| K874930 | MODEL 366-12 ADAPTAID(TM) STEP-DOWN ADAPTER | Intermedics, Inc. | 1988-01-06 | Traditional | PDF ↗ |
| K874167 | MEDTRONIC PERMANENT LEAD INTRODUCER | Medtronic Vascular | 1987-12-07 | Traditional | PDF ↗ |
| K873921 | MODEL 366-30 ADAPTAID(TM) ADAPTER SLEEVE | Intermedics, Inc. | 1987-12-03 | Traditional | PDF ↗ |
| K870885 | MEDTRONIC MODEL 5513 ENDOCARDIAL PACING LEAD | Medtronic Vascular | 1987-11-06 | Traditional | PDF ↗ |
| K873931 | MODIFIED MODELS 1025M & 1026T PACING LEAD | Pacesetter Systems | 1987-10-22 | Traditional | PDF ↗ |
| K872731 | PICF 0860/PSCF 0860/PSC 0860/PIAF 0860/PSAF 0860 | Ela Medical, Inc. | 1987-09-15 | Traditional | PDF ↗ |
| K865098 | SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, 030-438 | Telectronics, Inc. | 1987-08-18 | Traditional | PDF ↗ |
| K870016 | ARTERIAL BLOOD GASSING MONITORING SYSTEM (ABG) | Migada, Ltd. | 1987-05-28 | Traditional | PDF ↗ |
| K871580 | IMPLANTABLE PACING LEAD MODELS 487-06 TO 430-01 | Intermedics, Inc. | 1987-05-22 | Traditional | PDF ↗ |
| K864618 | IMPLANTABLE ELECTRODE LEAD, MODEL 030-439 | Telectronics, Inc. | 1987-05-21 | Traditional | PDF ↗ |
| K870357 | ELECTRODE, PACEMAKER, PERMANENT & TEMPORARY | Intermedics, Inc. | 1987-05-21 | Traditional | PDF ↗ |
| K871625 | MODEL 366-12 ADAPTAID (TM) STEP-DOWN ADAPTER | Intermedics, Inc. | 1987-05-21 | Traditional | PDF ↗ |
| K871333 | IMPLANTABLE TINED, TRANS. PACING LEAD/REVIS. LABEL | Medtronic Vascular | 1987-05-06 | Traditional | PDF ↗ |
| K870948 | MODEL 435-03 SIDE HOOK IMPLANTABLE PACING LEAD | Intermedics, Inc. | 1987-04-10 | Traditional | PDF ↗ |
| K870824 | ADDITIONAL CARDIAC PACING LEADS #1020 THROUGH 1035 | Pacesetter Systems | 1987-03-20 | Traditional | PDF ↗ |
| K870610 | RESUBMISSION OF MODEL 030-437 IMPLANT. ELECTRODE | Telectronics, Inc. | 1987-03-20 | Traditional | PDF ↗ |
| K870034 | MODEL PY...U UNIPOLAR & BIPOLAR PACING LEAD | Oscor Medical Corp. | 1987-03-03 | Traditional | PDF ↗ |
| K864326 | MODEL 366-13 ADAPTAID STEP DOWN ADAPTER | Intermedics, Inc. | 1987-01-16 | Traditional | PDF ↗ |
| K864601 | CCS POLYSAFE(TM) ENDOCARDIAL PACING LEAD | Cardiac Control Systems, Inc. | 1987-01-06 | Traditional | PDF ↗ |
| K862051 | MODEL 436-01 BIOPORE IMPLANTABLE PACING LEAD | Intermedics, Inc. | 1987-01-06 | Traditional | PDF ↗ |
| K864640 | ANCOR PERVENOUS ACTIVE FIXATION UNIPOLAR LEAD | Cordis Corp. | 1987-01-06 | Traditional | PDF ↗ |
| K864153 | PACE IMPLANT. LEAD/TINED/ATRIAL/J/MODEL 3290 | Pace Medical | 1987-01-06 | Traditional | PDF ↗ |
| K864738 | MODEL 366-14 INTERMEDICS LEAD CONNECTOR CAP | Intermedics, Inc. | 1987-01-06 | Traditional | PDF ↗ |
| K864856 | MODEL 5866-24 PACEMAKER LEAD ADAPTOR | Medtronic Vascular | 1987-01-06 | Traditional | PDF ↗ |
| K863536 | MEDTRONIC MODEL 5013 | Medtronic Vascular | 1987-01-06 | Traditional | PDF ↗ |
| K864428 | MODEL 366-23 ADAPTAID(TM) STEP-DOWN ADAPTER | Intermedics, Inc. | 1986-12-05 | Traditional | PDF ↗ |
| K864564 | MODEL 486-05 POLYFLEX(R) IMPLANTABLE PACING LEAD | Intermedics, Inc. | 1986-12-05 | Traditional | PDF ↗ |
| K864098 | TELECTRONICS SREW-IN/SLIM LINE PACING LEADS | Daig Corp. | 1986-12-05 | Traditional | PDF ↗ |
| K863921 | DAIG TYPE O4 VS-1 CONNECTOR | Daig Corp. | 1986-11-24 | Traditional | PDF ↗ |
| K864287 | MODEL 430-05 POLYFLEX IMPLANTABLE PACING LEAD | Intermedics, Inc. | 1986-11-20 | Traditional | PDF ↗ |
| K864002 | MODEL 431-06 POLYFLEX IMPLANTABLE PACING LEAD | Intermedics, Inc. | 1986-11-20 | Traditional | PDF ↗ |
| K864048 | MODEL 366-27 ADAPTAID(TM) STEP-DOWN ADAPTER | Intermedics, Inc. | 1986-11-03 | Traditional | PDF ↗ |
| K863781 | MODEL 493-08 POLYFLEX ENDOCARDIAL LEAD | Intermedics, Inc. | 1986-11-03 | Traditional | PDF ↗ |
| K864047 | MODEL 366-28 ADAPTAID(TM) STEP-DOWN ADAPTER | Intermedics, Inc. | 1986-11-03 | Traditional | PDF ↗ |
| K862966 | 3.2MM UNIPOLAR & BIPOLAR LEAD CONNECTORS (VS-1) | Oscor Medical Corp. | 1986-10-31 | Traditional | PDF ↗ |
| K863480 | BIOTRONIK PERMANENT PACEMAKER ELECTRODE | Biotronik Sales, Inc. | 1986-09-23 | Traditional | PDF ↗ |
Product code DTB · Class III · Cardiovascular. Data: openFDA.