VSI GUIDEWIRE


Device Classification Name

wire, guide, catheter

510(k) Number K112631
Device Name VSI GUIDEWIRE
Applicant
VASCULAR SOLUTIONS, INC.
6464 sycamore court north
minneapolis, 
MN 
55369

Applicant Contact melinda swanson
Correspondent
VASCULAR SOLUTIONS, INC.
6464 sycamore court north
minneapolis, 
MN 
55369

Correspodent Contact melinda swanson
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 09/09/2011
Decision Date 10/27/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No