K780772Substantially Equivalent

Bjork-Shiley Cardiac Heart Valve

Name: K780772 Bjork-Shiley Cardiac Heart Valve
Creator: Shiley, Inc.
Published: 1978-09-01
License: https://open.fda.gov/license/

Shiley, Inc., Mchenry IL / Traditional, Substantially Equivalent

FDA source

K780772 is the FDA 510(k) clearance record for BJORK-SHILEY CARDIAC HEART VALVE, cleared for Shiley, Inc. on 1978-09-01. FDA records list 174 510(k) clearances for Shiley, Inc., from 1976-11-19 to 1993-03-18. As of 2026-09-10, FDA records show no recalls naming K780772.

Clearance record

Decision date: 1978-09-01
Received: 1978-05-04 (120 days to decision)
Review panel: Unknown
Applicant: Shiley, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review: No