GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582


Device Classification Name

catheter, intravascular, diagnostic

510(k) Number K073200
Device Name GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582
Applicant
VASCULAR SOLUTIONS, INC.
6464 sycamore court
minneapolis, 
MN 
55369

Applicant Contact julie tapper
Correspondent
VASCULAR SOLUTIONS, INC.
6464 sycamore court
minneapolis, 
MN 
55369

Correspodent Contact julie tapper
Regulation Number 870.1200
Classification Product Code
DQO  
Date Received 11/13/2007
Decision Date 02/01/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No