FATHOM (TM) 14 STEERABLE GUIDEWIRE


Device Classification Name

wire, guide, catheter

510(k) Number K111498
Device Name FATHOM (TM) 14 STEERABLE GUIDEWIRE
Applicant
BOSTON SCIENTIFIC CORP.
one scimed place
maple grove, 
MN 
55311 -1566

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

Correspodent Contact eric elliott
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 05/31/2011
Decision Date 06/30/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Traditional
Reviewed by Third Party No

Combination Product

No