ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL: 106552


Device Classification Name

catheter, embolectomy

510(k) Number K072269
Device Name ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL: 106552
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  
Subsequent Product Code
KRA  
Date Received 08/15/2007
Decision Date 09/08/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No