D-STAT RADIAL HEMOSTATIC BAND


Device Classification Name

dressing, wound, drug

510(k) Number K050133
Device Name D-STAT RADIAL HEMOSTATIC BAND
Applicant
VASCULAR SOLUTIONS, INC.
6464 sycamore court
minneapolis, 
MN 
55369

Applicant Contact linda busklein
Correspondent
VASCULAR SOLUTIONS, INC.
6464 sycamore court
minneapolis, 
MN 
55369

Correspodent Contact linda busklein
Classification Product Code
FRO  
Date Received 01/21/2005
Decision Date 02/18/2005
Decision

substantially equivalent

(SESE)

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

Yes