Device Classification Name |
Catheter, Continuous Flush
|
510(k) Number |
K113773 |
Device Name |
ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL |
Applicant |
ST. JUDE MEDICAL |
15900 Valley View Court |
Sylmar,
CA
91342
|
|
Applicant Contact |
GEENA GEORGE |
Correspondent |
ST. JUDE MEDICAL |
15900 Valley View Court |
Sylmar,
CA
91342
|
|
Correspondent Contact |
GEENA GEORGE |
Regulation Number | 870.1210
|
Classification Product Code |
|
Date Received | 12/22/2011 |
Decision Date | 01/18/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|