K813220 is an FDA 510(k) clearance for the REGU-VAC OXYGENATING SUCTION CATHETER..
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on January 22, 1982, 74 days after receiving the submission on November 9, 1981.
This device falls under the Cardiovascular FDA review panel.
| 510(k) Number | K813220 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 1981 |
| Decision Date | January 22, 1982 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | — |
| Device Class | — |