Aesculap PAS-Port Proximal Anastomosis System

Clip, Implantable

Aesculap Inc.

The following data is part of a premarket notification filed by Aesculap Inc. with the FDA for Aesculap Pas-port Proximal Anastomosis System.

Pre-market Notification Details

Device IDK202124
510k NumberK202124
Device Name:Aesculap PAS-Port Proximal Anastomosis System
ClassificationClip, Implantable
Applicant Aesculap Inc. 3773 Corporate Parkway Center Valley,  PA  18034
ContactSierra Mertz
CorrespondentSierra Mertz
Aesculap Inc. 3773 Corporate Parkway Center Valley,  PA  18034
Product CodeFZP  
CFR Regulation Number878.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-31
Decision Date2020-09-02

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