M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETER


Device Classification Name

catheter, percutaneous

510(k) Number K112100
Device Name M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION 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 870.1250
Classification Product Code
DQY  
Date Received 07/22/2011
Decision Date 03/20/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No