K040569 is an FDA 510(k) clearance for the PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU. This device is classified as a Permanent Pacemaker Electrode (Class III - Premarket Approval, product code DTB).
Submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on April 7, 2004, 34 days after receiving the submission on March 4, 2004.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3680.
| 510(k) Number | K040569 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 2004 |
| Decision Date | April 07, 2004 |
| Days to Decision | 34 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DTB - Permanent Pacemaker Electrode |
| Device Class | Class III - Premarket Approval |
| CFR Regulation | 21 CFR 870.3680 |