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Lifesite Hemodialysis Access System/Cannula Exchange, Model LHAS14120 & LHCEK0000

by Vasca, Inc.

510(k) K001633

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 NumberK001633 Date24 Aug 2000ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0045-04 FDA Unclassified (pre-2012) initiated 22 Sep 2003

    Outer kit mislabeled with an extended expiration date

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  • Withdrawn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

Overview

AI-generated summary, 1 Oct 2026

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

The Lifesite Hemodialysis Access System/Cannula Exchange is a catheter, hemodialysis, implanted device designed to provide vascular access for hemodialysis patients. It consists of a fully implantable system with subcutaneous valves that facilitate repeated cannulation for dialysis procedures, reducing the need for temporary access methods like arteriovenous fistulas or grafts during the maturation phase.

This system is intended for single-use and requires surgical implantation by a healthcare professional. It is classified as a Class II medical device under FDA regulations (876.5540) and was cleared via a 510(k) submission in 2000. The cannula exchange components (Model LHCEK0000) are used to replace cannulas within the implanted system, ensuring continued functionality for hemodialysis access. Sterility and proper handling per manufacturer instructions are critical for safe use.

Other devices from Vasca, Inc.

Questions

AI-generated answers, 1 Oct 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 Lifesite Hemodialysis Access System/Cannula Exchange used for?

    The Lifesite Hemodialysis Access System/Cannula Exchange (Models LHAS14120 and LHCEK0000) is designed to provide vascular access for hemodialysis patients. It replaces traditional temporary access methods like arteriovenous fistulas or grafts during the maturation phase by offering a fully implantable system with subcutaneous valves. This allows repeated cannulation for dialysis procedures, improving convenience and reducing complications associated with temporary access.

  • How is the Lifesite Hemodialysis Access System/Cannula Exchange supplied and what are its key components?

    The system is supplied as a sterile, single-use device intended for surgical implantation by a healthcare professional. The primary component is the fully implantable cannula system (Model LHAS14120), while the cannula exchange components (Model LHCEK0000) are used to replace cannulas within the implanted system. Sterility and proper handling per manufacturer instructions are critical for safe use, as the device is not intended for reuse.

  • Is the Lifesite Hemodialysis Access System/Cannula Exchange reusable or single-use?

    The Lifesite Hemodialysis Access System/Cannula Exchange is explicitly designed for single-use only. The implanted system (Model LHAS14120) is intended for permanent placement, while the cannula exchange components (Model LHCEK0000) are also single-use replacements. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and patient safety.

  • What are the distinguishing features of the cannula exchange components (Model LHCEK0000)?

    The cannula exchange components (Model LHCEK0000) are designed to be compatible with the implanted Lifesite system (Model LHAS14120) and facilitate repeated cannulation for hemodialysis. They are intended to replace cannulas within the implanted system, ensuring continued functionality without requiring additional surgical procedures. The system includes subcutaneous valves that reduce the risk of infection and improve ease of use during dialysis sessions.

  • How should the Lifesite Hemodialysis Access System/Cannula Exchange be stored?

    The device must be stored in accordance with the manufacturer’s instructions to maintain sterility and functionality. Typically, this involves keeping the system in its original, sealed packaging until ready for use. Exposure to moisture, extreme temperatures, or contamination should be avoided, as these factors can compromise the device’s integrity. Always follow the provided storage guidelines to ensure safe and effective use.