K010787 is an FDA 510(k) clearance for the PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS. 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 May 22, 2001, 68 days after receiving the submission on March 15, 2001.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3620.
| 510(k) Number | K010787 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 15, 2001 |
| Decision Date | May 22, 2001 |
| Days to Decision | 68 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DTD - Pacemaker Lead Adaptor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3620 |