K781111Substantially Equivalent

Lead Conversion Kit, Model 341

Name: K781111 Lead Conversion Kit, Model 341
Creator: Edwards Pacemaker Systems
Published: 1978-08-31
License: https://open.fda.gov/license/

Edwards Pacemaker Systems, Mchenry IL / Traditional, Substantially Equivalent

FDA source

K781111 is the FDA 510(k) clearance record for LEAD CONVERSION KIT, MODEL 341, cleared for Edwards Pacemaker Systems on 1978-08-31. FDA records list 13 510(k) clearances for Edwards Pacemaker Systems, from 1977-03-07 to 1979-09-26. As of 2026-09-10, FDA records show no recalls naming K781111.

Clearance record

Decision date: 1978-08-31
Received: 1978-07-03 (59 days to decision)
Review panel: Unknown
Applicant: Edwards Pacemaker Systems 803 N. Front St. Suite 3, Mchenry IL
Third party review: No