K024156 is an FDA 510(k) clearance for the PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR. This device is classified as a Pacemaker Lead Adaptor (Class II - Special Controls, product code DTD).
Submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on January 14, 2003, 28 days after receiving the submission on December 17, 2002.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3620.
| 510(k) Number | K024156 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 2002 |
| Decision Date | January 14, 2003 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DTD - Pacemaker Lead Adaptor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3620 |