Z3 GUIDE CATHETER


Device Classification Name

catheter, percutaneous

510(k) Number K021256
Device Name Z3 GUIDE CATHETER
Original Applicant
MEDTRONIC VASCULAR
37a cherry hill dr.
danvers, 
MA 
01923

Original Contact fred l boucher
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 04/19/2002
Decision Date 05/17/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls