WILDCAT CATHETER


Device Classification Name

catheter for crossing total occlusions

510(k) Number K111338
Device Name WILDCAT CATHETER
Applicant
AVINGER, INC.
755 mathilda avenue
suite 100
sunnyvale, 
CA 
94085

Applicant Contact kit cariquitan
Correspondent
AVINGER, INC.
755 mathilda avenue
suite 100
sunnyvale, 
CA 
94085

Correspodent Contact kit cariquitan
Regulation Number 870.1250
Classification Product Code
PDU  
Date Received 05/12/2011
Decision Date 08/11/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Clinical Trials NCT01174784
Reviewed by Third Party No

Combination Product

No