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Terumo Arterial and Venous Blood Line Set

by Terumo Medical Corp.

510(k) K910558

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 NumberK910558 Date7 Aug 1991ClearedStatusActive

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  • Withdrawn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)

Full name
Terumo(R) Arterial and Venous Blood Line Set
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, 24 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 Terumo Arterial and Venous Blood Line Set is a medical device classified as a blood tubing set, which may include an anti-regurgitation valve. It is designed to facilitate the transport of blood within a clinical system.

This device is authorized for use under FDA 510(k) clearance. It is manufactured by Terumo Medical Corp. and is categorized under the gastroenterology and urology medical specialties.

From the manufacturer

TERUMO INTERVENTIONAL SYSTEMS (TIS) TIS is a market leader in providing solutions that enable minimally invasive entry site management, lesion access and therapeutic intervention for cardiology, peripheral arterial disease, embolotherapy and interventional oncology.

Source: terumomedical.com

Other devices from Terumo Medical Corporation

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Questions

AI-generated answers, 24 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 primary function of the Terumo Arterial and Venous Blood Line Set?

    This device is designed to facilitate the transport of blood within a clinical system. It serves as a blood tubing set to ensure proper flow during medical procedures.

  • Does the blood line set include any specialized components?

    Yes, the Terumo Arterial and Venous Blood Line Set may include an anti-regurgitation valve, depending on the specific configuration, to assist in managing blood flow.

  • What is the regulatory status of this device?

    The Terumo Arterial and Venous Blood Line Set is authorized for use under FDA 510(k) clearance, which indicates it has been found substantially equivalent to legally marketed predicate devices.

  • Which medical specialties is this device associated with?

    This device is categorized under the gastroenterology and urology medical specialties, as indicated by its regulatory classification and advisory committee oversight.