K830813 is an FDA 510(k) clearance for the FRENCH PERCUTANEOUS SHEATH INTRODUCER. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Norton Performance Plastics Corp. (Mchenry, US). The FDA issued a Cleared decision on April 28, 1983, 45 days after receiving the submission on March 14, 1983.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K830813 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 1983 |
| Decision Date | April 28, 1983 |
| Days to Decision | 45 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 |