Medical Device Manufacturer · US , Palo Alto , CA

Coapt Systems, Inc. - FDA 510(k) Cleared Devices

17 submissions · 17 cleared · Since 2002

17

Total

17

Cleared

0

Denied

FDA 510(k) Regulatory Record - Coapt Systems, Inc. Orthopedic ✕

8 devices

1-8 of 8

Cleared Jun 12, 2006

ULTRATINE TRANSBLEPH

Orthopedic · 132d

Cleared Jun 12, 2006

ULTRATINE FOREHEAD

Orthopedic · 132d

Cleared Nov 05, 2004

ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE

Orthopedic · 29d

Cleared Aug 27, 2004

ENDOTINE FOREHEAD TRIPLE DEVICE

Orthopedic · 25d

Cleared May 10, 2004

ENDOTINE TRANSBLEPH DEVICE

Orthopedic · 49d

Cleared Oct 08, 2003

ENDOTINE FOREHEAD DEVICE

Orthopedic · 30d

Cleared Dec 20, 2002

COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197

Orthopedic · 25d

Cleared Mar 15, 2002

COAPT SYSTMES ENDOTINE DEVICE

Orthopedic · 87d