DTD · Pacemaker Lead Adaptor
Cardiovascular · 21 CFR 870.3620 · Class 2
Overview
| Product Code | DTD |
|---|---|
| Device Name | Pacemaker Lead Adaptor |
| Regulation | 21 CFR 870.3620 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| Implant | Yes |
Identification
A pacemaker lead adaptor is a device used to adapt a pacemaker lead so that it can be connected to a pacemaker pulse generator produced by a different manufacturer.
Classification Rationale
Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions.”
Special Controls
*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions.”
Recent Cleared Devices (20 of 103)
Showing 20 most recent of 103 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K143463 | IS4/DF4 Port Plug | Oscor, Inc. | Mar 19, 2015 | SESE |
| K132008 | 6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP | Medtronic, Inc. | Jul 30, 2013 | SESE |
| K041574 | CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020 | Guidant Corporation | Jul 12, 2004 | SESE |
| K031164 | PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV | Oscor, Inc. | Jun 19, 2003 | ST |
| K024156 | PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR | Oscor, Inc. | Jan 14, 2003 | SESE |
| K010787 | PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS | Oscor, Inc. | May 22, 2001 | SESE |
| K003454 | A1-CS-SB Y-ADAPTER, MODEL 124 871 | Biotronik, Inc. | Jan 18, 2001 | ST |
| K000210 | MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT | Medtronic Vascular | Feb 23, 2000 | ST |
| K982220 | MODEL 2872 BIPOLAR LEAD ADAPTOR KIT | Medtronic Vascular | Oct 15, 1998 | ST |
| K971930 | BK-N SEALING CAP | Biotronik, Inc. | Aug 14, 1997 | PT |
| K970388 | A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVE | Biotronik, Inc. | Aug 14, 1997 | PT |
| K970204 | BK-A; BK-B; BK-IS SEALING CAP | Biotronik, Inc. | Apr 29, 1997 | SESE |
| K950140 | IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069 | Pacesetter, Inc. | Apr 6, 1995 | SESE |
| K934899 | BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM | Telectronics Pacing Systems, Inc. | May 12, 1994 | SESE |
| K925168 | MISCELLANEOUS PACING LEAD | Oscor Medical Corp. | May 3, 1994 | SESE |
| K921318 | ADAPTING SLEEVE KIT MODEL 4023 | Siemens-Pacesetter, Inc. | Aug 3, 1992 | SESE |
| K915724 | MODEL 6984M LEAD EXTENDER KIT | Medtronic Vascular | Feb 18, 1992 | SESE |
| K912773 | UNIPOLAR UPSIZING ADAPTOR | Telectronics Pacing Systems, Inc. | Oct 23, 1991 | SESE |
| K911142 | LEAD TERMINAL PIN CAPS, VARIOUS MODELS | Biotronik, GmbH & Co. | Aug 9, 1991 | SESE |
| K911302 | MODELS 5866-24M/5866-38M/5866-40M/6986M ADAPT KIT | Medtronic Vascular | Jul 30, 1991 | SESE |
Top Applicants
- Pacesetter Systems — 20 clearances
- Medtronic Vascular — 19 clearances
- Intermedics, Inc. — 14 clearances
- Telectronics, Inc. — 8 clearances
- Cardiac Pacemakers, Inc. — 5 clearances
