ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840


Device Classification Name

system, balloon, intra-aortic and control

510(k) Number K021462
Device Name ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840
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 05/07/2002
Decision Date 06/06/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls