K073559 is an FDA 510(k) clearance for the 18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II. This device is classified as a Cannula, Catheter (Class II - Special Controls, product code DQR).
Submitted by Edwards Lifesciences Research Medical (Midvale, US). The FDA issued a Cleared decision on January 31, 2008, 43 days after receiving the submission on December 19, 2007.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1300.
| 510(k) Number | K073559 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2007 |
| Decision Date | January 31, 2008 |
| Days to Decision | 43 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQR — Cannula, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1300 |