Device Classification Name |
clamp, vascular
|
510(k) Number |
K163693 |
Device Name |
IntraClude Intra-Aortic Occlusion Device |
Applicant |
Edwards Lifesciences LLC |
One Edwards Way |
Irvine,
CA
92614
|
|
Applicant Contact |
Lisa G. Hessabi |
Correspondent |
Edwards Lifesciences LLC |
One Edwards Way |
Irvine,
CA
92614
|
|
Correspondent Contact |
Lisa G. Hessabi |
Regulation Number | 870.4450
|
Classification Product Code |
|
Date Received | 12/28/2016 |
Decision Date | 01/26/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|