ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER


Device Classification Name

electrode, pacemaker, temporary

510(k) Number K960479
Device Name ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER
Applicant
ARROW INTL., INC.
3000 bernville rd.
reading, 
PA 
19605

Applicant Contact thomas d nickel
Correspondent
ARROW INTL., INC.
3000 bernville rd.
reading, 
PA 
19605

Correspodent Contact thomas d nickel
Regulation Number 870.3680
Classification Product Code
LDF  
Date Received 02/02/1996
Decision Date 10/17/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls