Medical Device Manufacturer · US , Cleveland , OH

Cardiac Assist Devices, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 1997

Recent clearances: GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E, MAGNO ALARM, GYRO TIP EP CATHETER

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Cardiac Assist Devices, Inc. Cardiovascular ✕

3 devices

1-3 of 3

Cleared Mar 27, 2002

GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E

Cardiovascular · 233d

Cleared Mar 26, 1997

Cardiovascular · 400d

Cleared Jan 29, 1997

GYRO TIP EP CATHETER

Cardiovascular · 400d