K843586 is an FDA 510(k) clearance for the THORA-KLEX AUTOTRANSFUSION KIT..
Submitted by C.R. Bard, Inc. (Murray Hill, US). The FDA issued a Cleared decision on October 25, 1984, 44 days after receiving the submission on September 11, 1984.
This device falls under the Cardiovascular FDA review panel.
| 510(k) Number | K843586 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 1984 |
| Decision Date | October 25, 1984 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | — |
| Device Class | — |