XTD THROMBECTOMY CATHETER, XX CM


Device Classification Name

catheter, embolectomy

510(k) Number K021641
Device Name XTD THROMBECTOMY CATHETER, XX CM
Original Applicant
XTRAK MEDICAL INC.
7 tiffany trail
hopkinton, 
MA 
01748

Original Contact debbie iampietro
Regulation Number 870.5150
Classification Product Code
DXE  
Date Received 05/20/2002
Decision Date 07/26/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No