BIPORE BALLOON DILATION CATHETER


Device Classification Name

catheter, angioplasty, peripheral, transluminal

510(k) Number K073318
Device Name BIPORE BALLOON DILATION CATHETER
Applicant
BIPORE, INC.
31 industrial pkwy.
northvale, 
NJ 
07647

Applicant Contact keith paluch
Correspondent
BIPORE, INC.
31 industrial pkwy.
northvale, 
NJ 
07647

Correspodent Contact keith paluch
Regulation Number 870.1250
Classification Product Code
LIT  
Date Received 11/26/2007
Decision Date 01/16/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Special
Reviewed by Third Party No

Combination Product

No