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Vas-Cath Peritoneal Dialysis Catheter

by Vas-Cath of Canada, Ltd.

510(k) K871817

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK871817 Date16 Jul 1987ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
FJS
FDA applicant
Vas-Cath of Canada , Ltd.
Device Class
Class II
Regulation
21 CFR Part 876.5630
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 VAS-CATH PERITONEAL DIALYSIS CATHETER is a medical device designed for peritoneal dialysis, a treatment used to filter waste and excess fluid from the blood when the kidneys are not functioning properly. It is a long-term indwelling catheter intended for use in patients requiring dialysis access.

The device is supplied sterile and is intended for single-use. It is a Class 2 device cleared by the FDA under the 510(k) pathway with product code FJS. The device is not MRI safe and should be stored in a dry, controlled environment until use.

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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 intended clinical use of the VAS-CATH Peritoneal Dialysis Catheter?

    It is designed for peritoneal dialysis, providing a permanent access route for patients whose kidneys cannot adequately filter waste and excess fluid. The catheter remains in the peritoneal cavity for long‑term use, allowing repeated exchanges of dialysis solution.

  • How is the catheter supplied and what are the sterility requirements?

    The device is supplied sterile and packaged for single‑use only. Sterility ensures that the catheter can be inserted without introducing infection, and because it is intended for one procedure, it must be discarded after use.

  • Can the catheter be reused or reprocessed after removal?

    No. The VAS-CATH catheter is labeled for single‑use only, meaning it is not intended to be reprocessed or reused. Reuse could compromise sterility and structural integrity, increasing the risk of infection or malfunction.

  • What storage conditions are recommended for the catheter before use?

    It should be stored in a dry, controlled environment until the time of implantation. Keeping the catheter away from moisture and extreme temperatures helps maintain its sterility and physical properties.

  • Is the catheter compatible with MRI procedures?

    The device is not MRI safe. Its materials may be affected by the magnetic field, and it could pose a safety hazard or become damaged if a patient undergoes MRI while the catheter is in place.