Device Classification Name |
catheter, oximeter, fiber-optic
|
510(k) Number |
K172423 |
Device Name |
PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter) |
Applicant |
Edwards Lifescience LLC |
One Edwards Way |
Ivine,
CA
92614
|
|
Applicant Contact |
Bedalin T. Lugo Rodriguez |
Correspondent |
Edwards Lifescience LLC |
One Edwards Way |
Ivine,
CA
92614
|
|
Correspondent Contact |
Bedalin T. Lugo Rodriguez |
Regulation Number | 870.1230
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/10/2017 |
Decision Date | 02/20/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|