Medical Device Manufacturer · US , Mchenry , IL

Aircast, Inc. - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 1978

11

Total

11

Cleared

0

Denied

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

7 devices

1-7 of 7

Cleared Jun 03, 2003

ARTERIALFLOW SYSTEM, MODEL 32A

Cardiovascular · 180d

Cleared Feb 10, 2003

VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER,...

Cardiovascular · 88d

Cleared Jan 13, 2000

VENAFLOW SYSTEM, MODEL 30A

Cardiovascular · 174d

Cleared Sep 08, 1997

AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS

Cardiovascular · 320d

Cleared Mar 28, 1997

AIRCAST VENAFLOW SYSTEM (MODIFICATION)

Cardiovascular · 350d

Cleared Dec 07, 1993

AIRCAST EDEMAFLOW SYSTEM

Cardiovascular · 116d

Cleared Oct 25, 1993

AIRCAST VENAFLOW SYSTEM

Cardiovascular · 133d