MODIFICATION TO: EXPORT CATHETER


Device Classification Name

catheter, embolectomy

510(k) Number K050139
Device Name MODIFICATION TO: EXPORT CATHETER
Applicant
MEDTRONIC VASCULAR
37a cherry hill dr.
danvers, 
MA 
01923

Applicant Contact fred l boucher
Correspondent
MEDTRONIC VASCULAR
37a cherry hill dr.
danvers, 
MA 
01923

Correspodent Contact fred l boucher
Regulation Number 870.5150
Classification Product Code
DXE  
Date Received 01/21/2005
Decision Date 03/22/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No