K010281 is an FDA 510(k) clearance for the MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP. This device is classified as a Permanent Pacemaker Electrode (Class III - Premarket Approval, product code DTB).
Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on April 9, 2002, 434 days after receiving the submission on January 30, 2001.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3680.
| 510(k) Number | K010281 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 2001 |
| Decision Date | April 09, 2002 |
| Days to Decision | 434 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTB — Permanent Pacemaker Electrode |
| Device Class | Class III - Premarket Approval |
| CFR Regulation | 21 CFR 870.3680 |