6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP
FDA 510(k) clearance K132008 · decided 2013-07-30
Clearance details
- K-number
- K132008
- Device name
- 6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP
- Applicant
- Medtronic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-07-01
- Decision date
- 2013-07-30
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- DTD
- Device class
- 2
- Regulation number
- 870.3620
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mounds View, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| IS4/DF4 Port Plug (K143463) | Oscor, Inc. | 2015-03-19 |
| CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020 (K041574) | Guidant Corporation | 2004-07-12 |
| PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV (K031164) | Oscor, Inc. | 2003-06-19 |
| PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR (K024156) | Oscor, Inc. | 2003-01-14 |
| PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS (K010787) | Oscor, Inc. | 2001-05-22 |
| A1-CS-SB Y-ADAPTER, MODEL 124 871 (K003454) | Biotronik, Inc. | 2001-01-18 |
| MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT (K000210) | Medtronic Vascular | 2000-02-23 |
| MODEL 2872 BIPOLAR LEAD ADAPTOR KIT (K982220) | Medtronic Vascular | 1998-10-15 |
| BK-N SEALING CAP (K971930) | Biotronik, Inc. | 1997-08-14 |
| A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVE (K970388) | Biotronik, Inc. | 1997-08-14 |
| BK-A; BK-B; BK-IS SEALING CAP (K970204) | Biotronik, Inc. | 1997-04-29 |
| IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069 (K950140) | Pacesetter, Inc. | 1995-04-06 |
Recalls involving this device
No recalls on record reference this clearance.
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