Submission Details
| 510(k) Number | K953044 FDA.gov |
| FDA Decision | Not Cleared PT (PT) |
| Date Received | June 30, 1995 |
| Decision Date | September 27, 1996 |
| Days to Decision | 455 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
Not Cleared
Traditional
K953044 - UNIPOLAR & BIOPLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION & PASSIVE FIXATION (FDA 510(k) Clearance)
Sep 1996
Decision
455d
Days
Class 3
Risk
K953044 is an FDA 510(k) submission for the UNIPOLAR & BIOPLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION & PASSIVE FIXATION. This device is classified as a Permanent Pacemaker Electrode (Class III - Premarket Approval, product code DTB).
Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Not Cleared (DENG) decision on September 27, 1996.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3680.
Device Classification
| Product Code | DTB — Permanent Pacemaker Electrode |
| Device Class | Class III - Premarket Approval |
| CFR Regulation | 21 CFR 870.3680 |