K945627 is an FDA 510(k) clearance for the PIKOS LP 01, PIKOS LP E01. 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 March 4, 1996, 474 days after receiving the submission on November 16, 1994.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3610.
| 510(k) Number | K945627 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Product Development Protocol (SESP) |
| Date Received | November 16, 1994 |
| Decision Date | March 04, 1996 |
| Days to Decision | 474 days |
| Submission Type | Traditional |
| 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 |