Medical Device Manufacturer · US , Blue Springs , MO

Intec Medical, Inc. - FDA 510(k) Cleared Devices

17 submissions · 17 cleared · Since 1980

17

Total

17

Cleared

0

Denied

FDA 510(k) Regulatory Record - Intec Medical, Inc. Cardiovascular ✕

8 devices

1-8 of 8

Cleared Jun 03, 1991

INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER

Cardiovascular · 39d

Cleared Oct 19, 1990

INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER

Cardiovascular · 247d

Cleared Oct 19, 1990

THE GUIDER CORONARY GUIDING CATHETER

Cardiovascular · 88d

Cleared Oct 19, 1990

TAPERED TIP THE GUIDER CORONARY GUIDING CATHETER

Cardiovascular · 88d

Cleared Oct 16, 1990

GIANT LUMEN SAFETIP SERIES: ENDOMYOCARDIAL BIOPSY

Cardiovascular · 56d

Cleared Sep 26, 1990

PERCUTANEOUS CATHETER INTRODUCER KIT

Cardiovascular · 34d

Cleared Aug 14, 1990

INTERVENTIONAL MEDICAL Y ADAPTER W/ADJUST. VALVE

Cardiovascular · 166d

Cleared Jul 31, 1990

TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES

Cardiovascular · 138d