K841535Substantially Equivalent

Triple Lumen Infusion Catheter/access

Name: K841535 Triple Lumen Infusion Catheter/access
Creator: Gish Biomedical, Inc.
Published: 1984-05-23
License: https://open.fda.gov/license/

Gish Biomedical, Inc., Mchenry IL / Traditional, Substantially Equivalent

FDA source

K841535 is the FDA 510(k) clearance record for TRIPLE LUMEN INFUSION CATHETER/ACCESS, cleared for Gish Biomedical, Inc. on 1984-05-23. FDA records list 75 510(k) clearances for Gish Biomedical, Inc., from 1983-08-31 to 2009-09-18. As of 2026-09-10, FDA records show no recalls naming K841535.

Clearance record

Decision date: 1984-05-23
Received: 1984-02-27 (86 days to decision)
Review panel: Unknown
Applicant: Gish Biomedical, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review: No