DTD — Pacemaker Lead Adaptor Class II
FDA product code DTD covers "Pacemaker Lead Adaptor", a Class II medical device regulated under 21 CFR 870.3620. Submissions are reviewed by the Cardiovascular panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DTD
- Device Class
- Class II
- Regulation Number
- 870.3620
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K143463 | oscor | IS4/DF4 Port Plug | March 19, 2015 |
| K132008 | medtronic | 6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866- | July 30, 2013 |
| K041574 | guidant corporation | CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020 | July 12, 2004 |
| K031164 | oscor | PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV | June 19, 2003 |
| K024156 | oscor | PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING L | January 14, 2003 |
| K010787 | oscor | PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS | May 22, 2001 |
| K003454 | biotronik | A1-CS-SB Y-ADAPTER, MODEL 124 871 | January 18, 2001 |
| K000210 | medtronic vascular | MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT | February 23, 2000 |
| K982220 | medtronic vascular | MODEL 2872 BIPOLAR LEAD ADAPTOR KIT | October 15, 1998 |
| K971930 | biotronik | BK-N SEALING CAP | August 14, 1997 |
| K970388 | biotronik | A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVE | August 14, 1997 |
| K970204 | biotronik | BK-A; BK-B; BK-IS SEALING CAP | April 29, 1997 |
| K950140 | pacesetter | IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069 | April 6, 1995 |
| K934899 | telectronics pacing systems | BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM | May 12, 1994 |
| K925168 | oscor medical | MISCELLANEOUS PACING LEAD | May 3, 1994 |
| K921318 | siemens-pacesetter | ADAPTING SLEEVE KIT MODEL 4023 | August 3, 1992 |
| K915724 | medtronic vascular | MODEL 6984M LEAD EXTENDER KIT | February 18, 1992 |
| K912773 | telectronics pacing systems | UNIPOLAR UPSIZING ADAPTOR | October 23, 1991 |
| K911142 | biotronik, gmbh and | LEAD TERMINAL PIN CAPS, VARIOUS MODELS | August 9, 1991 |
| K911302 | medtronic vascular | MODELS 5866-24M/5866-38M/5866-40M/6986M ADAPT KIT | July 30, 1991 |