A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVE
FDA 510(k) clearance K970388 · decided 1997-08-14
Clearance details
- K-number
- K970388
- Device name
- A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVE
- Applicant
- Biotronik, Inc.
- Decision
- Substantially Equivalent - Subject to Tracking & PMS
- Date received
- 1997-02-03
- Decision date
- 1997-08-14
- Days to decision
- 192 days
- Clearance type
- Traditional
- Product code
- DTD
- Device class
- 2
- Regulation number
- 870.3620
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Lake Oswego, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.