Submission Details
| 510(k) Number | K945627 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
PIKOS LP 01, PIKOS LP E01
Mar 1996
Decision
474d
Days
Class 3
Risk
About This 510(k) Submission
K945627 is an FDA 510(k) clearance for the PIKOS LP 01, PIKOS LP E01, 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 review panel. Regulated under 21 CFR 870.3610.
Device Classification
| Product Code | DXY — Implantable Pacemaker Pulse-generator |
| Device Class | Class III — Premarket Approval |
| CFR Regulation | 21 CFR 870.3610 |
Manufacturer
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