PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS


Device Classification Name

dilator, vessel, for percutaneous catheterization

510(k) Number K073035
Device Name PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS
Applicant
MERIT MEDICAL SYSTEMS, INC.
1600 west merit pkwy.
south jordan, 
UT 
84095

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

Correspodent Contact shirley hyink
Regulation Number 870.1310
Classification Product Code
DRE  
Date Received 10/29/2007
Decision Date 11/20/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No