GAZELLE BALLOON DILATATION CATHETER


information about

Device Classification Name

catheter, angioplasty, peripheral, transluminal

510(k) Number K001134
Device Name GAZELLE BALLOON DILATATION CATHETER
Original Applicant
BOSTON SCIENTIFIC CORP.
one boston scientific place
natick, 
MA 
01760

Original Contact jennifer bolton
Regulation Number 870.1250
Classification Product Code
LIT  
Date Received 04/10/2000
Decision Date 08/31/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Traditional
Reviewed by Third Party No

Combination Product

No