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Remote Access Perfusion (RAP) Femoral Venous Cannula

by Estech, Inc.

510(k) K052081

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK052081 Date16 Dec 2005ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0076-2018 FDA Class II initiated 28 Sep 2017

    A specific lot of the FlexFlowTM Venous Cannula, 200-200, is being recalled because it is sharper or pointier than expected.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

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

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Remote Access Perfusion (RAP) Femoral Venous Cannula is a vascular catheter, cannula, and tubing device designed for cardiopulmonary bypass applications. It is classified as a Class II medical device and is substantially equivalent to a predicate device under FDA 510(k) clearance K052081.

This device is supplied non-sterile and is intended for single use. It is used in cardiovascular procedures and is regulated under FDA regulation number 870.4210. The device is manufactured by Estech, Inc. and has been cleared for marketing in the United States.

Other devices from Estech, Inc.

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Remote Access Perfusion (RAP) Femoral Venous Cannula used for?

    It is designed for cardiopulmonary bypass applications as a vascular catheter, cannula, and tubing device used in cardiovascular procedures.

  • Is the RAP Femoral Venous Cannula sterile or non-sterile when supplied?

    The device is supplied non-sterile and is intended for single use, requiring sterilization by the user before clinical application.

  • What regulatory pathway was used for the RAP Femoral Venous Cannula?

    It received FDA 510(k) clearance under K052081 as substantially equivalent to a predicate device, classified as Class II under regulation 870.4210.