VASCULAR ASSIST


Device Classification Name

flowmeter, blood, cardiovascular

510(k) Number K002186
Device Name VASCULAR ASSIST
Original Applicant
HUNTLEIGH HEALTHCARE, INC.
40 christopher way
eatontown, 
NJ 
07724 -3327

Original Contact audrey a witko
Regulation Number 870.2100
Classification Product Code
DPW  
Subsequent Product Codes
JAF   JOM  
Date Received 07/20/2000
Decision Date 05/02/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls