KINETIX GUIDEWIRE, PLUS GUIDEWIRE


Device Classification Name

wire, guide, catheter

510(k) Number K081021
Device Name KINETIX GUIDEWIRE, PLUS GUIDEWIRE
Applicant
BOSTON SCIENTIFIC CORP.
one scimed place a-380
maple grove, 
MN 
55301

Applicant Contact christine thomas
Correspondent
BOSTON SCIENTIFIC CORP.
one scimed place a-380
maple grove, 
MN 
55301

Correspodent Contact christine thomas
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 04/10/2008
Decision Date 08/08/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No