FLEXOR EVAC ASPIRATION CATHETER


Device Classification Name

catheter, embolectomy

510(k) Number K073627
Device Name FLEXOR EVAC ASPIRATION CATHETER
Applicant
COOK, INC.
750 daniels way
p.o. box 489
bloomington, 
IN 
47402

Applicant Contact karen bradburn
Correspondent
COOK, INC.
750 daniels way
p.o. box 489
bloomington, 
IN 
47402

Correspodent Contact karen bradburn
Regulation Number 870.5150
Classification Product Code
DXE  
Date Received 12/26/2007
Decision Date 03/04/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No