K823357 is an FDA 510(k) clearance for the VARIOUS CARDIOVASCULAR PRODUCTS. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by C.R. Bard, Inc. (Warrendale, US). The FDA issued a Cleared decision on March 11, 1983, 126 days after receiving the submission on November 5, 1982.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K823357 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 1982 |
| Decision Date | March 11, 1983 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DQO — Catheter, Intravascular, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |