ENGAGE/ENGAGE TR INTRODUCERS


Device Classification Name

introducer, catheter

510(k) Number K111092
Device Name ENGAGE/ENGAGE TR INTRODUCERS
Applicant
ST. JUDE MEDICAL
14901 deveau pl.
minnetonka, 
MN 
55345 -2126

Applicant Contact venkata damaraju
Correspondent
ST. JUDE MEDICAL
14901 deveau pl.
minnetonka, 
MN 
55345 -2126

Correspodent Contact venkata damaraju
Regulation Number 870.1340
Classification Product Code
DYB  
Date Received 04/19/2011
Decision Date 06/09/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No