MERIT MEDICAL SYSTEMS, INC., GUIDE WIRE TORQUE DEVICE


Device Classification Name

wire, guide, catheter

510(k) Number K072552
Device Name MERIT MEDICAL SYSTEMS, INC., GUIDE WIRE TORQUE DEVICE
Applicant
MERIT MEDICAL SYSTEMS, INC.
1600 west merit pkwy.
south jordan, 
UT 
84095

Applicant Contact william d jordan
Correspondent
MERIT MEDICAL SYSTEMS, INC.
1600 west merit pkwy.
south jordan, 
UT 
84095

Correspodent Contact william d jordan
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 09/10/2007
Decision Date 12/14/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No