ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS


Device Classification Name

catheter, embolectomy

510(k) Number K072769
Device Name ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS
Applicant
POSSIS MEDICAL, INC.
9055 evergreen blvd., n.w.
minneapolis, 
MN 
55433 -8003

Applicant Contact mike burnside
Correspondent
POSSIS MEDICAL, INC.
9055 evergreen blvd., n.w.
minneapolis, 
MN 
55433 -8003

Correspodent Contact mike burnside
Regulation Number 870.5150
Classification Product Code
DXE  
Date Received 09/28/2007
Decision Date 11/14/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No