K821004 is an FDA 510(k) clearance for the MEDTRONIC S3 TM SYSTEM. This device is classified as a Catheter, Flow Directed (Class II - Special Controls, product code DYG).
Submitted by Medtronic Vascular (Walker, US). The FDA issued a Cleared decision on May 25, 1982, 46 days after receiving the submission on April 9, 1982.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1240.
| 510(k) Number | K821004 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 09, 1982 |
| Decision Date | May 25, 1982 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DYG — Catheter, Flow Directed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1240 |