ULTRA-SOFT SV BALLOON DILATATION CATHETER


Device Classification Name

catheter, percutaneous

510(k) Number K050389
Device Name ULTRA-SOFT SV BALLOON DILATATION CATHETER
Applicant
BOSTON SCIENTIFIC CORP.
two scimed place
maple grove, 
MN 
55311 -1566

Applicant Contact angie byland
Correspondent
BOSTON SCIENTIFIC CORP.
two scimed place
maple grove, 
MN 
55311 -1566

Correspodent Contact angie byland
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 02/15/2005
Decision Date 05/25/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No