AGILLS PF DELIVERY SYSTEM


Device Classification Name

introducer, catheter

510(k) Number K111943
Device Name AGILLS PF DELIVERY SYSTEM
Applicant
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
15900 valley view ct.
sylmar, 
CA 
91342

Applicant Contact geena george
Correspondent
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
15900 valley view ct.
sylmar, 
CA 
91342

Correspodent Contact geena george
Regulation Number 870.1340
Classification Product Code
DYB  
Date Received 07/08/2011
Decision Date 09/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No