Medical Device Manufacturer · US , Mchenry , IL

Intensive Technology, Inc. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 1981

12

Total

12

Cleared

0

Denied

FDA 510(k) Regulatory Record - Intensive Technology, Inc. Cardiovascular ✕

9 devices

1-9 of 9

Cleared Jan 13, 1993

INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM

Cardiovascular · 208d

Cleared Aug 24, 1992

TEC ROTATING DUAL HEMOVALVE

Cardiovascular · 433d

Cleared Oct 16, 1991

IVT GUIDING CATHETER

Cardiovascular · 173d

Cleared Jan 03, 1991

IVT INTRODUCER SHEATH

Cardiovascular · 155d

Cleared Jun 28, 1990

MODIFIED IVT PERIPHERAL ATHERECTOMY

Cardiovascular · 72d

Cleared Mar 06, 1990

MODIFIED IVT PERIPHERAL ATHERECTOMY SYSTEM

Cardiovascular · 119d

Cleared Jan 04, 1990

IVT 0.014 GUIDE WIRE

Cardiovascular · 90d

Cleared May 23, 1989

PERIPHERAL ATHERECTOMY SYSTEM

Cardiovascular · 111d

Cleared Oct 28, 1988

0.014 PERIPHERAL GUIDE WIRE

Cardiovascular · 113d