CANALIZER HYDROPHILIC GUIDE WIRE


Device Classification Name

wire, guide, catheter

510(k) Number K050873
Device Name CANALIZER HYDROPHILIC GUIDE WIRE
Applicant
MEDICAL DEVICE TECHNOLOGIES, INC.
3600 sw 47th avenue
gainesville, 
FL 
32608

Applicant Contact kristine liberacki
Correspondent
MEDICAL DEVICE TECHNOLOGIES, INC.
3600 sw 47th avenue
gainesville, 
FL 
32608

Correspodent Contact kristine liberacki
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 04/06/2005
Decision Date 05/26/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No