K003454 is an FDA 510(k) clearance for the A1-CS-SB Y-ADAPTER, MODEL 124 871. 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 January 18, 2001, 72 days after receiving the submission on November 7, 2000.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3620.
| 510(k) Number | K003454 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Third Party Review (ST) |
| Date Received | November 07, 2000 |
| Decision Date | January 18, 2001 |
| Days to Decision | 72 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DTD — Pacemaker Lead Adaptor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3620 |