BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER


Device Classification Name

catheter, percutaneous

510(k) Number K021735
Device Name BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER
Original Applicant
BOSTON SCIENTIFIC SCIMED, INC.
one scimed place
maple grove, 
MN 
55311

Original Contact candice burns
Regulation Number 870.1250
Classification Product Code
DQY  
Subsequent Product Code
LIT  
Date Received 05/28/2002
Decision Date 08/08/2002
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