K832595 is an FDA 510(k) clearance for the VESSEL DILATOR. This device is classified as a Dilator, Vessel, Surgical (Class II - Special Controls, product code DWP).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 31, 1983, 29 days after receiving the submission on August 2, 1983.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4475.
| 510(k) Number | K832595 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 1983 |
| Decision Date | August 31, 1983 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DWP — Dilator, Vessel, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4475 |