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14 Fr. Hemodialysis Two-Lumen Catheterization Kit

by Arrow Intl., Inc.

510(k) K991431

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 · Special NumberK991431 Date26 May 1999ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0639-04 FDA Unclassified (pre-2012) initiated 18 Feb 2004

    catheter slips out of the suture wing during use.

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  • Withdrawn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
MPB
Device Class
Class II
Regulation
21 CFR Part 876.5540
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 14 Fr. Hemodialysis Two-Lumen Catheterization Kit is a non-implanted hemodialysis catheter designed for temporary or short-term hemodialysis and apheresis. It features two independent, non-communicating lumens, extension lines, Luer hubs, and clamps, with a distal tip made of soft, pliable material and centimeter markings on the body to facilitate positioning.

This device is supplied as a kit for vascular access and is regulated under FDA 510K authorization. It is classified as a class 2 medical device under regulation number 876.5540.

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Questions

AI-generated answers, 26 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 intended use of this catheterization kit?

    The 14 Fr. Hemodialysis Two-Lumen Catheterization Kit is designed for temporary or short-term vascular access to perform hemodialysis and apheresis procedures.

  • How is the catheter designed to assist with placement?

    The catheter features a soft, pliable distal tip to minimize trauma during insertion and includes centimeter markings along the body to help clinicians accurately position the device.

  • What are the primary components of the catheter system?

    The device consists of two independent, non-communicating lumens, which allow for separate flow paths. It also includes extension lines, Luer hubs, and clamps to manage the connection and flow during the dialysis process.

  • What is the regulatory status of this device?

    This device is regulated under FDA 510K authorization as a class 2 medical device, falling under regulation number 876.5540 for non-implanted hemodialysis catheters.