STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS


Device Classification Name

catheter, angioplasty, peripheral, transluminal

510(k) Number K080982
Device Name STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS
Applicant
BOSTON SCIENTIFIC CORP.
one scimed place
maple grove, 
MN 
55311 -1566

Applicant Contact mark murphy
Correspondent
BOSTON SCIENTIFIC CORP.
one scimed place
maple grove, 
MN 
55311 -1566

Correspodent Contact mark murphy
Regulation Number 870.1250
Classification Product Code
LIT  
Date Received 04/07/2008
Decision Date 07/14/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No