HI-TORQUE PILOT 50 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE PILOT 150 GUIDE WIRE WITH HYDROCOAT HYDROPHG


Device Classification Name

wire, guide, catheter

510(k) Number K030549
Device Name HI-TORQUE PILOT 50 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE PILOT 150 GUIDE WIRE WITH HYDROCOAT HYDROPHG
Applicant
GUIDCORP
26531 ynez rd.
temecula, 
CA 
92591

Applicant Contact stacey brown
Correspondent
GUIDCORP
26531 ynez rd.
temecula, 
CA 
92591

Correspodent Contact stacey brown
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 02/21/2003
Decision Date 05/14/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No