RUBICON SUPPORT CATHETER


Device Classification Name

catheter, percutaneous

510(k) Number K112303
Device Name RUBICON SUPPORT CATHETER
Applicant
BOSTON SCIENTIFIC
one scimed place
maple grove, 
MN 
55311 -1566

Applicant Contact glenn jacques
Correspondent
BOSTON SCIENTIFIC
one scimed place
maple grove, 
MN 
55311 -1566

Correspodent Contact glenn jacques
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 08/11/2011
Decision Date 11/09/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No