ANGIOJET SOLENT OMNI THROMBECTOMY SET


Device Classification Name

catheter, embolectomy

510(k) Number K111182
Device Name ANGIOJET SOLENT OMNI THROMBECTOMY SET
Applicant
MEDRAD, INC.
9055 evergreen blvd nw
minneapolis, 
MN 
55433 -8003

Applicant Contact doug atkins
Correspondent
MEDRAD, INC.
9055 evergreen blvd nw
minneapolis, 
MN 
55433 -8003

Correspodent Contact doug atkins
Regulation Number 870.5150
Classification Product Code
DXE  
Subsequent Product Code
KRA  
Date Received 04/27/2011
Decision Date 05/24/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No