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PureFlex Arterial Cannulae

by Sorin Group Italia S.R.L. United States 510(k)

510(k) K180979 Product code DWF

Overview

The PureFlex Arterial Cannulae is a vascular catheter and cannula system designed for cardiopulmonary bypass and extracorporeal membrane oxygenation procedures. It functions as an arterial access device to deliver oxygenated blood from the extracorporeal circuit back to the patient. The device is classified under the FDA product code DWF for catheter, cannula and tubing used in vascular and cardiopulmonary bypass applications.

The device is supplied as a single-use, sterile unit intended for clinical settings requiring arterial cannulation during cardiac surgery or ECMO support. It is available in various sizes, including a 20 French model with a straight collar tip and flange configuration. Storage conditions and handling must follow the manufacturer’s instructions to maintain sterility and integrity. The device is regulated under FDA 510(k) clearance with reference number K180979 and is listed in the GUDID database under the identifier 3009211636.

Summary written by AI from registry data, 25 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK180979 Date16 Nov 2018ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
DWF
Device Class
Class II
Regulation
21 CFR Part 870.4210
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the PureFlex Arterial Cannulae used for?

    It is used as an arterial access device to deliver oxygenated blood from an extracorporeal circuit back to the patient during cardiopulmonary bypass or extracorporeal membrane oxygenation (ECMO) procedures.

  • How is the device supplied?

    It is supplied as a single-use, sterile unit intended for clinical settings. The device must be stored and handled according to the manufacturer’s instructions to maintain sterility and integrity.

  • Is the PureFlex Arterial Cannulae reusable?

    No, it is a single-use device. Reuse or reprocessing is not indicated and may compromise sterility, structural integrity, and patient safety.

  • What sizes are available?

    The device is available in various sizes, including a 20 French model with a straight collar tip and flange configuration. Other sizes may be offered, but the 20 French is specifically documented in the regulatory filing.

  • What regulatory pathway was used for clearance?

    The device was cleared under the FDA 510(k) pathway with reference number K180979. It is classified under FDA product code DWF for catheter, cannula and tubing used in vascular and cardiopulmonary bypass applications.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K180979 24 fields · synced 22 Oct 2026