Device Classification Name |
catheter, flow directed
|
510(k) Number |
K222117 |
Device Name |
Swang-Ganz IQ pulmonary artery catheter |
Applicant |
Edwards Lifesiences, LLC |
1 Edwards Way |
Irvine,
CA
92614
|
|
Applicant Contact |
Michelle Ducca |
Correspondent |
Edwards Lifesiences, LLC |
1 Edwards Way |
Irvine,
CA
92614
|
|
Correspondent Contact |
Michelle Ducca |
Regulation Number | 870.1240
|
Classification Product Code |
|
Date Received | 07/18/2022 |
Decision Date | 12/09/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|