PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A
FDA 510(k) clearance K993434 · decided 1999-11-10
Clearance details
- K-number
- K993434
- Device name
- PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A
- Applicant
- Biotronik, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-10-12
- Decision date
- 1999-11-10
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- DXY
- Device class
- 3
- Regulation number
- 870.3610
- 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.