Submission Details
| 510(k) Number | K993434 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Special
PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A
Nov 1999
Decision
29d
Days
Class 3
Risk
About This 510(k) Submission
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, 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 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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