K863000Substantially Equivalent

Astra 2,3,4 and 6: Chip Revision

Name: K863000 Astra 2,3,4 and 6: Chip Revision
Creator: Cardiac Pacemakers, Inc.
Published: 1986-08-19
License: https://open.fda.gov/license/

Cardiac Pacemakers, Inc., St. Paul MN / Traditional, Substantially Equivalent

FDA source

K863000 is the FDA 510(k) clearance record for ASTRA 2,3,4 AND 6: CHIP REVISION, cleared for Cardiac Pacemakers, Inc. on 1986-08-19. FDA records list 76 510(k) clearances for Cardiac Pacemakers, Inc., from 1977-01-12 to 2010-03-05. As of 2026-09-10, FDA records show no recalls naming K863000.

Clearance record

Decision date: 1986-08-19
Received: 1986-08-08 (11 days to decision)
Review panel: Unknown
Applicant: Cardiac Pacemakers, Inc. 4100 Hamline Ave., N., St. Paul MN
Third party review: No