K902674 is an FDA 510(k) clearance for the DATASCOPE ARTERIAL CANNULA W/ACCESS PORT. This device is classified as a Cannula, Catheter (Class II - Special Controls, product code DQR).
Submitted by Datascope Corp. (Oakland, US). The FDA issued a Cleared decision on January 16, 1991, 212 days after receiving the submission on June 18, 1990.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1300.
| 510(k) Number | K902674 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 18, 1990 |
| Decision Date | January 16, 1991 |
| Days to Decision | 212 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Product Code | DQR - Cannula, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1300 |