K843258Substantially Equivalent

Angio Sys Brachial Angio Drape

Name: K843258 Angio Sys Brachial Angio Drape
Creator: Angiosystems, Inc.
Published: 1984-09-21
License: https://open.fda.gov/license/

Angiosystems, Inc., Mchenry IL / Traditional, Substantially Equivalent

FDA source

K843258 is the FDA 510(k) clearance record for ANGIO SYS BRACHIAL ANGIO DRAPE, cleared for Angiosystems, Inc. on 1984-09-21. FDA records list 14 510(k) clearances for Angiosystems, Inc., from 1984-09-11 to 1991-05-31. As of 2026-09-10, FDA records show no recalls naming K843258.

Clearance record

Decision date: 1984-09-21
Received: 1984-08-20 (32 days to decision)
Review panel: Unknown
Applicant: Angiosystems, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review: No