Device Classification Name |
Clip, Implantable
|
510(k) Number |
K202124 |
Device Name |
Aesculap PAS-Port Proximal Anastomosis System |
Applicant |
Aesculap Inc. |
3773 Corporate Parkway |
Center Valley,
PA
18034
|
|
Applicant Contact |
Sierra Mertz |
Correspondent |
Aesculap Inc. |
3773 Corporate Parkway |
Center Valley,
PA
18034
|
|
Correspondent Contact |
Sierra Mertz |
Regulation Number | 878.4300
|
Classification Product Code |
|
Date Received | 07/31/2020 |
Decision Date | 09/02/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|