BENELLI ACCESS DEVICE


Device Classification Name

catheter, percutaneous

510(k) Number K111334
Device Name BENELLI ACCESS DEVICE
Applicant
VASCULAR SOLUTIONS, INC.
6464 sycamore court north
minneapolis, 
MN 
55369

Applicant Contact jennifer ruether
Correspondent
VASCULAR SOLUTIONS, INC.
6464 sycamore court north
minneapolis, 
MN 
55369

Correspodent Contact jennifer ruether
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 05/12/2011
Decision Date 08/01/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No