NITREX NITINOL GUIDEWIRE


Device Classification Name

wire, guide, catheter

510(k) Number K024021
Device Name NITREX NITINOL GUIDEWIRE
Original Applicant
EV3 CORPORATION
4600 nathan ln.
plymouth, 
MN 
55442 -2920

Original Contact phil neururer
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 12/05/2002
Decision Date 01/24/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No