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Ash Advance Hemodialysis Catheter and Procedure Kit, Models; 15Fr X 24cm, 15Fr X 28cm, 15Fr X 32cm

by Ash Access Technology, Inc.

510(k) K070572

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 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)SESK Substantially Equivalent — Kit · Traditional NumberK070572 Date26 Jun 2007ClearedStatusActive

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-2396-2008 FDA Unclassified (pre-2012) initiated 7 Jul 2008
    • Terminated Z-2397-2008 FDA Unclassified (pre-2012) initiated 7 Jul 2008
    • Terminated Z-2398-2008 FDA Unclassified (pre-2012) initiated 7 Jul 2008

    The cuff may be inadequately attached to the catheter, resulting in possible catheter movement or leakage at the insertion site.

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  • Withdrawn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
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 876.5540
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESK Substantially Equivalent — Kit

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 Ash Advance Hemodialysis Catheter and Procedure Kit is an implanted hemodialysis catheter designed for long-term vascular access. This radiopaque, dual-lumen Carbothane device features a fixed-length split-tip design with a venous lumen that extends beyond the arterial lumen, a polyester cuff for anchoring, and an integrated hub with color-coded extension sets.

This device is supplied as a kit and has received FDA 510(k) clearance. It is available in three sizes: 15FR X 24CM, 15FR X 28CM, and 15FR X 32CM.

Other devices from Ash Access Technology, Inc.

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 intended use of the Ash Advance Hemodialysis Catheter?

    The Ash Advance is designed for long-term vascular access in patients requiring hemodialysis. It features a dual-lumen, radiopaque Carbothane construction with a split-tip design to facilitate effective blood flow during dialysis procedures.

  • What sizes are available for this catheter kit?

    The Ash Advance Hemodialysis Catheter and Procedure Kit is available in three specific sizes to accommodate different patient needs: 15FR x 24cm, 15FR x 28cm, and 15FR x 32cm.

  • How is the catheter secured in the patient?

    The device includes a polyester cuff, which is designed to anchor the catheter securely within the tissue, providing stability for long-term use.

  • Has this device received regulatory authorization?

    Yes, the Ash Advance Hemodialysis Catheter and Procedure Kit has received FDA 510(k) clearance, which indicates that the device has been reviewed and authorized for market distribution in the United States.