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Cardica PAS-Port Proximal Anastomosis System

FDA UDI

Class II (US FDA UDI)

by Aesdex, Llc

Identity

Trade Name
Cardica PAS-Port Proximal Anastomosis System FDA UDI
Generic Name
Vascular-grafting anastomosis system FDA UDI
Device Name
PAS-Port Proximal Anastomosis System FDA UDI
Model / Reference
FG-000001 FDA UDI
Description
PAS-Port Proximal Anastomosis System FDA UDI

Identifiers

Catalog Number
FG-000001 FDA UDI
Primary DI / UDI-DI
11814900000017 FDA UDI
510(k) Number
K091017 FDA UDI
FDA Product Code
FZP FDA UDI
GMDN Term
Vascular-grafting anastomosis system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Vascular-grafting anastomosis system

Cardica PAS-Port Proximal Anastomosis System by Aesdex, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular-grafting anastomosis system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Aesdex, Llc

Sources (1)

  • FDA UDI a2885cb9-3060-4173-b553-3df422c0bd46 35 fields · synced Jun 1, 2026