K842780 is an FDA 510(k) clearance for the MEDTRONIC 6210 PERMANENT LEAD INTRODUC. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Medtronic Vascular (Walker, US). The FDA issued a Cleared decision on August 3, 1984, 18 days after receiving the submission on July 16, 1984.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K842780 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 1984 |
| Decision Date | August 03, 1984 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DYB — Introducer, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1340 |