ISOFLOW INFUSION CATHETER


Device Classification Name

catheter, continuous flush

510(k) Number K081147
Device Name ISOFLOW INFUSION CATHETER
Applicant
VASCULAR DESIGNS INC.
3722 ave. sausalito
irvine, 
CA 
92606

Applicant Contact grace holland
Correspondent
VASCULAR DESIGNS INC.
3722 ave. sausalito
irvine, 
CA 
92606

Correspodent Contact grace holland
Regulation Number 870.1210
Classification Product Code
KRA  
Subsequent Product Code
DQY  
Date Received 04/22/2008
Decision Date 05/29/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No