K970204 is an FDA 510(k) clearance for the BK-A. 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 Cleared decision on April 29, 1997, 98 days after receiving the submission on January 21, 1997.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3620.
| 510(k) Number | K970204 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 1997 |
| Decision Date | April 29, 1997 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTD — Pacemaker Lead Adaptor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3620 |