K864167Substantially Equivalent

Percluder(tm)-Dl Occluding Balloon(heparin Coated)

Name: K864167 Percluder(tm)-Dl Occluding Balloon(heparin Coated)
Creator: Datascope Corp.
Published: 1986-11-06
License: https://open.fda.gov/license/

Datascope Corp., Oakland NJ / Traditional, Substantially Equivalent

FDA source

K864167 is the FDA 510(k) clearance record for PERCLUDER(TM)-DL OCCLUDING BALLOON(HEPARIN COATED), cleared for Datascope Corp. on 1986-11-06. 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 K864167.

Clearance record

Decision date: 1986-11-06
Received: 1986-10-24 (13 days to decision)
Review panel: Unknown
Applicant: Datascope Corp. 3 Fir Ct., Oakland NJ
Third party review: No