Skip to content

Arteriovenous Blood Tubing Sets

by Extracorporeal Medical Specialities, Inc. 3 variants

510(k) K780681

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK780681 Date14 Jun 1978ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
FJK
Device Class
Class II
Regulation
21 CFR Part 876.5820
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

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

Arteriovenous Blood Tubing Sets are medical devices used as part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions. These sets facilitate blood flow during extracorporeal procedures, connecting the patient's vascular access to the hemodialysis machine.

The device is supplied as a tubing set and may include anti-regurgitation valves. It is a Class II device cleared by the FDA under 510(k) K780681. The device is manufactured by Extracorporeal Medical Specialties, Inc. and is registered under product code FJK, with regulatory authorization under 876.5820.

Other devices from Extracorporeal Medical Specialities, Inc.

See all devices from Extracorporeal Medical Specialities, Inc. →

Questions

AI-generated answers, 28 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 are Arteriovenous Blood Tubing Sets used for?

    These tubing sets are used as part of an artificial kidney system for treating patients with renal failure or toxemic conditions. They facilitate blood flow during extracorporeal procedures by connecting the patient's vascular access to the hemodialysis machine.

  • How are Arteriovenous Blood Tubing Sets supplied?

    The device is supplied as a tubing set and may include anti-regurgitation valves. It is manufactured by Extracorporeal Medical Specialties, Inc. and is designed specifically for use in hemodialysis procedures.

  • What is the regulatory status of these tubing sets?

    The Arteriovenous Blood Tubing Sets are Class II devices cleared by the FDA under 510(k) K780681. They are registered under product code FJK with regulatory authorization under 876.5820.

  • Are these tubing sets single-use or reusable?

    The device description does not specify whether these tubing sets are single-use or reusable. This information would typically be found in the product's instructions for use or labeling materials provided by the manufacturer.