PRONTO LOW PROFILE (LP) EXTRACTION CATHETER, MODEL 5010


Device Classification Name

catheter, embolectomy

510(k) Number K072810
Device Name PRONTO LOW PROFILE (LP) EXTRACTION CATHETER, MODEL 5010
Applicant
VASCULAR SOLUTIONS, INC.
6464 sycamore court
minneapolis, 
MN 
55369

Applicant Contact doralie poganski
Correspondent
VASCULAR SOLUTIONS, INC.
6464 sycamore court
minneapolis, 
MN 
55369

Correspodent Contact doralie poganski
Regulation Number 870.5150
Classification Product Code
DXE  
Date Received 10/01/2007
Decision Date 12/19/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No