AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX


Device Classification Name

catheter, percutaneous

510(k) Number K111704
Device Name AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX
Applicant
AVINGER, INC.
400 chesapeake drive
redwood city, 
CA 
94063

Applicant Contact sevrina ciucci, rac
Correspondent
AVINGER, INC.
400 chesapeake drive
redwood city, 
CA 
94063

Correspodent Contact sevrina ciucci, rac
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 06/17/2011
Decision Date 09/09/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Traditional
Reviewed by Third Party No

Combination Product

No