K993434 is an FDA 510(k) clearance for the PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A. This device is classified as a Implantable Pacemaker Pulse-generator (Class III - Premarket Approval, product code DXY).
Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on November 10, 1999, 29 days after receiving the submission on October 12, 1999.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3610.
| 510(k) Number | K993434 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 12, 1999 |
| Decision Date | November 10, 1999 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXY — Implantable Pacemaker Pulse-generator |
| Device Class | Class III - Premarket Approval |
| CFR Regulation | 21 CFR 870.3610 |