TWIN-PASS OTW CATHETER, MODEL 5201


Device Classification Name

catheter, percutaneous

510(k) Number K072618
Device Name TWIN-PASS OTW CATHETER, MODEL 5201
Applicant
VASCULAR SOLUTIONS, INC.
6464 sycamore court
minneapolis, 
MN 
55369

Applicant Contact alyssa malinski
Correspondent
VASCULAR SOLUTIONS, INC.
6464 sycamore court
minneapolis, 
MN 
55369

Correspodent Contact alyssa malinski
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 09/17/2007
Decision Date 11/21/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No