ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040, 105042, 106552, 105043, 105041, 106553, 105039

Device Classification Name

catheter, embolectomy

510(k) Number K071342
Device Name ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040, 105042, 106552, 105043, 105041, 106553, 105039
Applicant
POSSIS MEDICAL, INC.
9055 evergreen blvd., n.w.
minneapolis, 
MN 
55433 -8003

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

Correspodent Contact mark stenoien
Regulation Number 870.5150
Classification Product Code
DXE  
Subsequent Product Code
KRA  
Date Received 05/14/2007
Decision Date 07/31/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No