BRK TRANSSEPTAL NEEDLE


Device Classification Name

trocar

510(k) Number K072278
Device Name BRK TRANSSEPTAL NEEDLE
Applicant
ST. JUDE MEDICAL
14901 deveau pl.
minnetonka, 
MN 
55345 -2126

Applicant Contact laura moen-ftacek
Regulation Number 870.1390
Classification Product Code
DRC  
Date Received 08/16/2007
Decision Date 09/13/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No