Medical Device Manufacturer · US , Plymouth , MN

Invatec Innovative Technologies, S.R.L. - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2005

7

Total

7

Cleared

0

Denied

FDA 510(k) Regulatory Record - Invatec Innovative Technologies, S.R.L. Cardiovascular ✕

7 devices

1-7 of 7

Cleared Mar 13, 2009

AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER

Cardiovascular · 72d

Cleared Nov 04, 2005

MODIFICATION TO: AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER

Cardiovascular · 32d

Cleared Aug 08, 2005

DIVER C.E. CATHETER

Cardiovascular · 24d

Cleared May 05, 2005

SKIPPER AND SKIPPER RACE GUIDEWIRE

Cardiovascular · 43d

Cleared Mar 07, 2005

DIVER C.E. CATHETER

Cardiovascular · 28d

Cleared Feb 11, 2005

MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER

Cardiovascular · 30d

Cleared Jan 10, 2005

AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER

Cardiovascular · 105d