ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608


Device Classification Name

catheter, embolectomy

510(k) Number K080806
Device Name ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608
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 03/21/2008
Decision Date 04/04/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No