WILDCAT 5F GUIDEWIRE SUPPORT CATHETER


Device Classification Name

catheter, percutaneous

510(k) Number K112579
Device Name WILDCAT 5F GUIDEWIRE SUPPORT CATHETER
Applicant
AVINGER, INC.
400 chesapeake drive
redwood city, 
CA 
94063

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

Correspodent Contact sevrina ciucci
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 09/06/2011
Decision Date 10/06/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No