Medical Device Manufacturer · US , San Diego , CA

Boston Scientific /International Technologies - FDA 510(k) Cleared De...

5 submissions · 5 cleared · Since 1994

Recent clearances: IVT 0.014 PTFE-COATED TRACKWIRE

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Boston Scientific /International Technologies Cardiovascular ✕

5 devices

1-5 of 5

Cleared Dec 11, 1997

IVT 0.014 PTFE-COATED TRACKWIRE

Cardiovascular · 218d

Cleared Jan 13, 1997

11F GUIDING CATHETER

Cardiovascular · 122d

Cleared Apr 29, 1996

Cardiovascular · 210d

Cleared Apr 29, 1996

IVT 0.014 TRACK OR IVT 0.014 ACCUTRACK

Cardiovascular · 207d

Cleared Mar 15, 1994

PROTECTOR INTRODUCER SHEATH

Cardiovascular · 392d