K843258 is an FDA 510(k) clearance for the ANGIO SYS BRACHIAL ANGIO DRAPE..
Submitted by Angiosystems, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 21, 1984, 32 days after receiving the submission on August 20, 1984.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K843258 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 20, 1984 |
| Decision Date | September 21, 1984 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | — |
| Device Class | — |