K863608Substantially Equivalent

Datascope Balloon Dilatation Catheter

Name: K863608 Datascope Balloon Dilatation Catheter
Creator: Datascope Corp.
Published: 1987-02-10
License: https://open.fda.gov/license/

Datascope Corp., Oakland NJ / Traditional, Substantially Equivalent

FDA source

K863608 is the FDA 510(k) clearance record for DATASCOPE BALLOON DILATATION CATHETER, cleared for Datascope Corp. on 1987-02-10. FDA records list 139 510(k) clearances for Datascope Corp., from 1976-10-20 to 2019-12-26. As of 2026-09-10, FDA records show no recalls naming K863608.

Clearance record

Decision date: 1987-02-10
Received: 1986-09-16 (147 days to decision)
Review panel: Unknown
Applicant: Datascope Corp. 3 Fir Ct., Oakland NJ
Third party review: No