FDA Product Code
FDA Product Code DTD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.3620
510(k) Clearances — 103 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K143463 | IS4/DF4 Port Plug | Oscor, Inc. | 2015-03-19 | Traditional | PDF ↗ |
| K132008 | 6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP | Medtronic, Inc. | 2013-07-30 | Special | PDF ↗ |
| K041574 | CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020 | Guidant Corporation | 2004-07-12 | Special | PDF ↗ |
| K031164 | PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV | Oscor, Inc. | 2003-06-19 | Special | PDF ↗ |
| K024156 | PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR | Oscor, Inc. | 2003-01-14 | Special | PDF ↗ |
| K010787 | PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS | Oscor, Inc. | 2001-05-22 | Traditional | PDF ↗ |
| K003454 | A1-CS-SB Y-ADAPTER, MODEL 124 871 | Biotronik, Inc. | 2001-01-18 | Special | PDF ↗ |
| K000210 | MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT | Medtronic Vascular | 2000-02-23 | Special | PDF ↗ |
| K982220 | MODEL 2872 BIPOLAR LEAD ADAPTOR KIT | Medtronic Vascular | 1998-10-15 | Traditional | PDF ↗ |
| K971930 | BK-N SEALING CAP | Biotronik, Inc. | 1997-08-14 | Traditional | PDF ↗ |
| K970388 | A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVE | Biotronik, Inc. | 1997-08-14 | Traditional | PDF ↗ |
| K970204 | BK-A; BK-B; BK-IS SEALING CAP | Biotronik, Inc. | 1997-04-29 | Traditional | PDF ↗ |
| K950140 | IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069 | Pacesetter, Inc. | 1995-04-06 | Traditional | PDF ↗ |
| K934899 | BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM | Telectronics Pacing Systems, Inc. | 1994-05-12 | Traditional | PDF ↗ |
| K925168 | MISCELLANEOUS PACING LEAD | Oscor Medical Corp. | 1994-05-03 | Traditional | PDF ↗ |
| K921318 | ADAPTING SLEEVE KIT MODEL 4023 | Siemens-Pacesetter, Inc. | 1992-08-03 | Traditional | PDF ↗ |
| K915724 | MODEL 6984M LEAD EXTENDER KIT | Medtronic Vascular | 1992-02-18 | Traditional | PDF ↗ |
| K912773 | UNIPOLAR UPSIZING ADAPTOR | Telectronics Pacing Systems, Inc. | 1991-10-23 | Traditional | PDF ↗ |
| K911142 | LEAD TERMINAL PIN CAPS, VARIOUS MODELS | Biotronik, GmbH & Co. | 1991-08-09 | Traditional | PDF ↗ |
| K911302 | MODELS 5866-24M/5866-38M/5866-40M/6986M ADAPT KIT | Medtronic Vascular | 1991-07-30 | Traditional | PDF ↗ |
| K911827 | MODEL 5866-9M & MODEL 6981M | Metronic, Inc. | 1991-07-23 | Traditional | PDF ↗ |
| K910630 | MODEL 6985M TEMPORARY UNIPOLAR LEAD EXTENDER KIT | Medtronic Vascular | 1991-04-18 | Traditional | PDF ↗ |
| K911048 | MODEL 5857-3M LEAD END CAP KIT | Medtronic Vascular | 1991-04-18 | Traditional | PDF ↗ |
| K910112 | BIFURCATED VS-1 TO VS-1 LEAD ADAPTOR | Telectronics Pacing Systems, Inc. | 1991-02-25 | Traditional | PDF ↗ |
| K904575 | MODEL 5866-37M LEAD ADAPTOR KIT | Medtronic Vascular | 1991-02-01 | Traditional | PDF ↗ |
| K902889 | A1-A,A1-B,A1-ABP,A1-MBP,A1-Z,A6-A,A6-B,PEH PACE. | Biotronik, GmbH & Co. | 1990-08-23 | Traditional | PDF ↗ |
| K900512 | SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERS | Pacesetter Systems | 1990-06-25 | Traditional | PDF ↗ |
| K900627 | MODEL 5866-34 LEAD ADAPTOR KIT | Medtronic Vascular | 1990-04-20 | Traditional | PDF ↗ |
| K896438 | UPSIZING LEAD ADAPTERS 5.0MM PEEL-AWAY ADAPTER | Telectronics Pacing Systems, Inc. | 1990-04-10 | Traditional | PDF ↗ |
| K900605 | 3.2-5MM UNIPOLAR LEAD UPSIZING KIT, MODEL AK 100 | Possis Medical, Inc. | 1990-03-06 | Traditional | PDF ↗ |
| K890895 | IMPLANTABLE ADAPTOR 033-380 | Telectronics, Inc. | 1990-03-06 | Traditional | PDF ↗ |
| K895971 | TELECTRONICS PACING SYSTEMS VS-1 TO 6MM UPSIZING | Telectronics Pacing Systems, Inc. | 1990-02-22 | Traditional | PDF ↗ |
| K894976 | ALTERNATE PACKAGING CONF. OF PACEMAKER LEAD ADAP. | Medtronic Vascular | 1989-10-12 | Traditional | PDF ↗ |
| K894718 | ADAPTAID(TM) ADAPTER SLEEVE MODEL 366-33 | Intermedics, Inc. | 1989-09-05 | Traditional | PDF ↗ |
| K870562 | DAIG PACEMAKER LEAD ADAPTOR | Daig Corp. | 1987-03-03 | Traditional | PDF ↗ |
| K862656 | PACEMAKER LEAD ADAPTER | Cordis Corp. | 1986-07-30 | Traditional | PDF ↗ |
| K860832 | MODEL 366-08 ADAPTAID CONNECTOR ADAPTER | Intermedics, Inc. | 1986-03-31 | Traditional | PDF ↗ |
| K854997 | IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLY | Telectronics, Inc. | 1986-02-12 | Traditional | PDF ↗ |
| K844814 | BIOPORE 493-05 ENDOCARDIAL IMPLANTABLE PACING LEAD | Intermedics, Inc. | 1985-08-29 | Traditional | PDF ↗ |
| K850968 | MEDTRONIC MODEL 4016 BIPOLAR ENDOCARDIAL SCREW-IN | Medtronic Vascular | 1985-08-29 | Traditional | PDF ↗ |
| K851897 | CCS MODEL AV-106 IMPLANTABLE A-V DATA LEAD | Cardiac Control Systems, Inc. | 1985-08-09 | Traditional | PDF ↗ |
| K852356 | MEDTRONIC MODEL 5561 | Medtronic Vascular | 1985-08-06 | Traditional | PDF ↗ |
| K852253 | 329 CORDIS ENCOR PREVENOUS ARTRIAL & VENTRICULAR | Cordis Corp. | 1985-07-29 | Traditional | PDF ↗ |
| K851457 | MODEL 483-06 POLYFLEX IMPLANTABLE PACING LEAD | Intermedics, Inc. | 1985-07-11 | Traditional | PDF ↗ |
| K851458 | MODEL 493-04 POLYFLEX R IMPLANTABLE PACING LEAD | Intermedics, Inc. | 1985-07-11 | Traditional | PDF ↗ |
| K851890 | MEDTRONIC 5064 | Medtronic Vascular | 1985-06-19 | Traditional | PDF ↗ |
| K851665 | PACESETTER SYSTEMS, MODEL 458 ADAPTER SLEEVE | Pacesetter Systems | 1985-05-21 | Traditional | PDF ↗ |
| K851145 | PACESETTER SYSTEMS INC. ENDOCARDIAL FINNED LEAD | Pacesetter Systems | 1985-04-19 | Traditional | PDF ↗ |
| K850652 | PACESETTER SYSTEMS, ENDOCARDIAL FIRM LEAD | Pacesetter Systems | 1985-04-10 | Traditional | PDF ↗ |
| K850576 | PACESETTER SYS, ENDOCARDIAL, VENTRICULAR, BIPOLAR | Pacesetter Systems | 1985-03-06 | Traditional | PDF ↗ |
| K844974 | MEDTRONIC 5061 ENDOCARDIAL PACING LEAD | Medtronic Vascular | 1985-03-06 | Traditional | PDF ↗ |
| K844857 | PACESETTER SYSTEMS, INC. ENDOCARDIAL SCREW-IN LEAD | Pacesetter Systems | 1985-02-14 | Traditional | PDF ↗ |
| K841450 | BIOTRONIK DNP UNIPOLAR | Biotronik Sales, Inc. | 1985-02-07 | Traditional | PDF ↗ |
| K841451 | BIOTRONIK DY-UNIPOLAR | Biotronik Sales, Inc. | 1985-02-07 | Traditional | PDF ↗ |
| K844687 | MEDTRONIC MODEL 6912 | Medtronic Vascular | 1985-02-01 | Traditional | PDF ↗ |
| K842065 | EPICARDIAL, UNIPOLAR LEAD 4951 | Medtronic Vascular | 1985-01-18 | Traditional | PDF ↗ |
| K842145 | TRANSVENOUS TINED VENTRICULAR LEAD | Medtronic Vascular | 1985-01-18 | Traditional | PDF ↗ |
| K843703 | PERMATHANE 865 & 867 UNIPOLAR POLYURETH | Pacesetter Systems | 1985-01-08 | Traditional | PDF ↗ |
| K841227 | BIPOLAR ENDOCARDIAL LEAD 406L | Siemens Elema AB | 1984-11-27 | Traditional | PDF ↗ |
| K843060 | SENTRA | Cardiac Pacemakers, Inc. | 1984-09-20 | Traditional | PDF ↗ |
| K841739 | MODEL 866 PERMATHANE BIPOLAR, COAXIAL | Pacesetter Systems | 1984-08-03 | Traditional | PDF ↗ |
| K841885 | FASTPASS IMPLANTABLE ENDOCARDIAL PAC | Pacesetter Systems | 1984-08-03 | Traditional | PDF ↗ |
| K840025 | IMPLANTABLE ELECTRODE BIPOLAR ADAPT | Telectronics, Inc. | 1984-05-23 | Traditional | PDF ↗ |
| K840026 | IMPLANTABLE ELECTRODE UNIPOLAR ADAPT | Telectronics, Inc. | 1984-05-23 | Traditional | PDF ↗ |
| K831160 | LEAD ADAPTERS #'S 6016,6022,6017 ETC | Cardiac Pacemakers, Inc. | 1983-05-09 | Traditional | PDF ↗ |
| K822704 | MODEL 366-07 ADAPT AID LEAD ADAPTER | Intermedics, Inc. | 1982-11-24 | Traditional | PDF ↗ |
| K821548 | PACEMAKER CONNECTOR PLUG | Pacesetter Systems | 1982-06-02 | Traditional | PDF ↗ |
| K821547 | PACEMAKER UNIPOLAR ADAPTER | Pacesetter Systems | 1982-06-02 | Traditional | PDF ↗ |
| K821549 | PACEMAKER 445 ADAPTER | Pacesetter Systems | 1982-06-02 | Traditional | PDF ↗ |
| K820935 | MODEL 5866-26 LEAD ADAPTER KIT | Medtronic Vascular | 1982-04-16 | Traditional | PDF ↗ |
| K813152 | ELECTRODE TERMINAL CAP | Pacesetter Systems | 1981-12-02 | Traditional | PDF ↗ |
| K813154 | ADAPTING SLEEVE | Pacesetter Systems | 1981-12-02 | Traditional | PDF ↗ |
| K813151 | VITATRON INSERT | Pacesetter Systems | 1981-12-02 | Traditional | PDF ↗ |
| K812756 | ADAPTAID #365-38 | Intermedics, Inc. | 1981-10-29 | Traditional | PDF ↗ |
| K812812 | INTERMEDICS ADAPTAID STEP-DOWN ADAPTER | Intermedics, Inc. | 1981-10-27 | Traditional | PDF ↗ |
| K811920 | ADAPTAID LEAD ADAPTER, #365-17 | Intermedics, Inc. | 1981-08-13 | Traditional | PDF ↗ |
| K811938 | ADAPTAID LEAD ADAPTER #365-25 | Intermedics, Inc. | 1981-08-07 | Traditional | PDF ↗ |
| K811349 | MODEL 5866-24 LEAD ADAPTOR KIT | Medtronic Vascular | 1981-06-30 | Traditional | PDF ↗ |
| K810551 | PACEMAKER LEAD ADAPTER | Pacesetter Systems | 1981-04-23 | Traditional | PDF ↗ |
| K810245 | IMPLANTABLE PACEMAKER LEAD ADAPTER | Intermedics, Inc. | 1981-03-04 | Traditional | PDF ↗ |
| K802407 | PACEMAKER LEAD ADAPTOR MODEL 431 | Pacesetter Systems | 1980-10-31 | Traditional | PDF ↗ |
| K802077 | UNIPOLAR TO BIPOLAR PULSE GEN. ADAPTER | Cardiac Pacemakers, Inc. | 1980-10-23 | Traditional | PDF ↗ |
| K801039 | ADAPTAID HELICAL COIL ADAPTER 365-14 | Intermedics, Inc. | 1980-07-21 | Traditional | PDF ↗ |
| K801038 | ADAPTAID ELEMA LEAD ADAPTER KIT 365-17 | Intermedics, Inc. | 1980-07-08 | Traditional | PDF ↗ |
| K801040 | GE LEAD ADAPTER, MODEL 345-01 | Intermedics, Inc. | 1980-06-30 | Traditional | PDF ↗ |
| K800353 | ADAPTER KIT | Daig Corp. | 1980-05-28 | Traditional | PDF ↗ |
| K790218 | BIPOLAR LEAD ADAPTOR, MODEL BA-415 | Pacesetter Systems | 1979-08-10 | Traditional | PDF ↗ |
| K790436 | IMPLANTABLE HEART LEAD TERMINAL ADAPTER | Arco Medical Products Co. | 1979-05-14 | Traditional | PDF ↗ |
| K790468 | IMPLANTABLE HEART LEAD EXTENDER | Arco Medical Products Co. | 1979-03-19 | Traditional | PDF ↗ |
| K781823 | ELECTRODE, MODEL 030-326 | Telectronics, Inc. | 1979-02-08 | Traditional | PDF ↗ |
| K781822 | ELECTRODE, MODEL 030-324 | Telectronics, Inc. | 1979-02-08 | Traditional | PDF ↗ |
| K781824 | ELECTRODE, MODEL 030-324/4 GUAGE | Telectronics, Inc. | 1979-02-08 | Traditional | PDF ↗ |
| K782097 | ELECTRODE LEAD MODEL 030-198 | Telectronics, Inc. | 1978-12-22 | Traditional | PDF ↗ |
| K781864 | ADAPTER KIT | Daig Corp. | 1978-12-19 | Traditional | PDF ↗ |
| K781627 | PACING LEAD ADAPTER MODEL ADB 21 | R.E. Brown Co., Inc. | 1978-12-08 | Traditional | PDF ↗ |
| K781626 | PACING LEAD ADAPTER, ACV 14, ACV 23 | R.E. Brown Co., Inc. | 1978-12-08 | Traditional | PDF ↗ |
| K781622 | PACING LEAD ADAPTER MODEL ACS 16 | R.E. Brown Co., Inc. | 1978-12-08 | Traditional | PDF ↗ |
| K772058 | LEAD ADAPTOR KIT MODEL 5866-21 | Medtronic Vascular | 1977-11-03 | Traditional | PDF ↗ |
| K771641 | UNIVERSAL LEAD ADAPTER, UA-414 | Pacesetter Systems | 1977-09-14 | Traditional | PDF ↗ |
| K771642 | ADAPTER A-413 | Pacesetter Systems | 1977-09-14 | Traditional | PDF ↗ |
Product code DTD · Class II · Cardiovascular. Data: openFDA.