Medical Device Manufacturer · GB , Worksop

Chalice Medical , Ltd. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2020

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Chalice Medical , Ltd. Cardiovascular ✕

3 devices

1-3 of 3

Cleared Nov 01, 2023

CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)

Cardiovascular · 169d

Cleared Sep 18, 2020

Paragon Adult Maxi PMP Oxygenator with Tubing Pack

Cardiovascular · 93d

Cleared Feb 28, 2020

Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)

Cardiovascular · 295d