Medical Device Manufacturer · IL , Caesaria

Keystone Heart, Ltd. - FDA 510(k) Cleared Devices

1 submissions · 1 cleared · Since 2020

Recent clearances: Lim Precision Steerable TS, Steerable Sheath, Dilator

View 1 510(k) Devices ↓

1

Total

1

Cleared

0

Denied

FDA 510(k) Regulatory Record - Keystone Heart, Ltd. Cardiovascular ✕

1 devices

1-1 of 1

Cleared Dec 15, 2020

Lim Precision Steerable TS, Steerable Sheath, Dilator

Cardiovascular · 130d

Data Source

Sourced from the FDA 510(k) public files . 176,583 total devices indexed.

Last updated: May 29, 2026