Submission Details
| 510(k) Number | K970388 FDA.gov |
| FDA Decision | Not Cleared PT (PT) |
| Date Received | February 03, 1997 |
| Decision Date | August 14, 1997 |
| Days to Decision | 192 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
Not Cleared
Traditional
K970388 - A1-A,ABP,B,MBP, LEAD CONNECTORS (FDA 510(k) Clearance)
Also includes:
PEH ADAPTER SLEEVE
Aug 1997
Decision
192d
Days
Class 2
Risk
K970388 is an FDA 510(k) submission for the A1-A,ABP,B,MBP, LEAD CONNECTORS. This device is classified as a Pacemaker Lead Adaptor (Class II - Special Controls, product code DTD).
Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Not Cleared (DENG) decision on August 14, 1997.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3620.
Device Classification
| Product Code | DTD — Pacemaker Lead Adaptor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3620 |