Keystone Heart, Ltd. is one of 267 FDA 510(k) medical device manufacturers from Israel in the dataset, ranked by real submission volume.
Keystone Heart, Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Lim Precision Steerable TS, Steerable Sheath, Dilator
1
Total
1
Cleared
0
Denied
Keystone Heart, Ltd. has 1 FDA 510(k) cleared medical devices. Based in Caesaria, IL.
Historical record: 1 cleared submissions from 2020 to 2020. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Keystone Heart, Ltd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Winegar Consulting, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Keystone Heart, Ltd.
1 devices