XL EXTRACTION CATHETER


Device Classification Name

catheter, embolectomy

510(k) Number K112571
Device Name XL EXTRACTION CATHETER
Applicant
VASCULAR SOLUTIONS, INC.
6464 sycamore court north
minneapolis, 
MN 
55369

Applicant Contact matt nienstedt
Correspondent
VASCULAR SOLUTIONS, INC.
6464 sycamore court north
minneapolis, 
MN 
55369

Correspodent Contact matt nienstedt
Regulation Number 870.5150
Classification Product Code
DXE  
Date Received 09/06/2011
Decision Date 10/06/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No