K800462 is an FDA 510(k) clearance for the PERCUTANEOUS INTRODUCER SET. This device is classified as a Dilator, Vessel, For Percutaneous Catheterization (Class II - Special Controls, product code DRE).
Submitted by Medical Components, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 19, 1980, 19 days after receiving the submission on February 29, 1980.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1310.
| 510(k) Number | K800462 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 29, 1980 |
| Decision Date | March 19, 1980 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DRE — Dilator, Vessel, For Percutaneous Catheterization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1310 |