GUIDELINER V2 CATHETER


Device Classification Name

catheter, percutaneous

510(k) Number K112082
Device Name GUIDELINER V2 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 07/21/2011
Decision Date 12/01/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls