VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER, MODEL 3017


Device Classification Name

sleeve, limb, compressible

510(k) Number K023800
Device Name VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER, MODEL 3017
Original Applicant
AIRCAST, INC.
92 river rd.
summit, 
NJ 
07902

Original Contact stephen l kenney
Regulation Number 870.5800
Classification Product Code
JOW  
Date Received 11/14/2002
Decision Date 02/10/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No