ACUITY WHISPER VIEW GUIDE WIRES


Device Classification Name

wire, guide, catheter

510(k) Number K110479
Device Name ACUITY WHISPER VIEW GUIDE WIRES
Applicant
BOSTON SCIENTIFIC CORP.
4100 hamline ave north
st. paul, 
MN 
55112

Applicant Contact kirstin johnston
Correspondent
BOSTON SCIENTIFIC CORP.
4100 hamline ave north
st. paul, 
MN 
55112

Correspodent Contact kirstin johnston
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 02/18/2011
Decision Date 04/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No