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
|
|
Correspondent Contact |
GEENA GEORGE |
Regulation Number | 870.1340
|
Classification Product Code |
|
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
|
|
|