TRAXCESS 0.014 HYDROPHILIC GUIDEWIRE


Device Classification Name

wire, guide, catheter

510(k) Number K080863
Device Name TRAXCESS 0.014 HYDROPHILIC GUIDEWIRE
Applicant
MICROVENTION, INC.
75 columbia
suite a
aliso viejo, 
CA 
92656 -1408

Applicant Contact kevin e daly
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 03/28/2008
Decision Date 04/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No