ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP


Device Classification Name

system, balloon, intra-aortic and control

510(k) Number K002256
Device Name ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP
Original Applicant
ARROW INTL., INC.
9 plymouth st.
everett, 
MA 
02149

Original Contact william paquin
Regulation Number 870.3535
Classification Product Code
DSP  
Date Received 07/25/2000
Decision Date 05/03/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Traditional
Reviewed by Third Party No

Combination Product

No