ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8F


Device Classification Name

catheter, percutaneous

510(k) Number K111252
Device Name ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8F
Applicant
BOSTON SCIENTIFIC CORP.
one scimed place
maple grove, 
MN 
55311 -1566

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

Correspodent Contact holly ramirez
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 05/03/2011
Decision Date 06/02/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No