DAIG PACEMAKER LEAD ADAPTOR
FDA 510(k) clearance K870562 · decided 1987-03-03
Clearance details
- K-number
- K870562
- Device name
- DAIG PACEMAKER LEAD ADAPTOR
- Applicant
- Daig Corp.
- Decision
- Substantially Equivalent
- Date received
- 1987-02-10
- Decision date
- 1987-03-03
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- DTD
- Device class
- 2
- Regulation number
- 870.3620
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minnetonka, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Enpath Lead Adapter, Ref: 501214. The contents of the inner package have been sterilized b recall (Z-0580-2010) | Greatbatch Medical | 2009-12-29 |
| Enpath Lead Adapters, pacemaker lead adapter. Affects: 5 mm Bipolar, Model 501205; 6 mm Un recall (Z-0120-2007) | Enpath Medical, Inc | 2006-11-09 |