MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F)


Device Classification Name

introducer, catheter

510(k) Number K023447
Device Name MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F)
Original Applicant
ST. JUDE MEDICAL
14901 deveau pl.
minnetonka, 
MN 
55345 -2126

Original Contact glenn jacques
Regulation Number 870.1340
Classification Product Code
DYB  
Date Received 10/15/2002
Decision Date 10/31/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No