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14.5 Fr Chronic Hemodialysis Catheter With Heparin Coating and Silver Impregnated Sleeve (Palindrome Sapphire)

by Kendall

510(k) K062671

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

24 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 · Special NumberK062671 Date3 Nov 2006ClearedStatusActive

Recalls

24 recalls · FDA

  • 24 recalls, same reason

    • Terminated Z-1893-2015 FDA Class II initiated 23 Apr 2015
    • Terminated Z-1897-2015 FDA Class II initiated 23 Apr 2015
    • Terminated Z-1891-2015 FDA Class II initiated 23 Apr 2015
    • Terminated Z-1909-2015 FDA Class II initiated 23 Apr 2015
    • Terminated Z-1900-2015 FDA Class II initiated 23 Apr 2015
    • Terminated Z-1892-2015 FDA Class II initiated 23 Apr 2015
    • Terminated Z-1888-2015 FDA Class II initiated 23 Apr 2015
    • Terminated Z-1903-2015 FDA Class II initiated 23 Apr 2015
    • Terminated Z-1910-2015 FDA Class II initiated 23 Apr 2015
    • Terminated Z-1902-2015 FDA Class II initiated 23 Apr 2015
    • Terminated Z-1905-2015 FDA Class II initiated 23 Apr 2015
    • Terminated Z-1904-2015 FDA Class II initiated 23 Apr 2015
    • Terminated Z-1901-2015 FDA Class II initiated 23 Apr 2015
    • Terminated Z-1895-2015 FDA Class II initiated 23 Apr 2015
    • Terminated Z-1896-2015 FDA Class II initiated 23 Apr 2015
    • Terminated Z-1899-2015 FDA Class II initiated 23 Apr 2015
    • Terminated Z-1911-2015 FDA Class II initiated 23 Apr 2015
    • Terminated Z-1894-2015 FDA Class II initiated 23 Apr 2015
    • Terminated Z-1906-2015 FDA Class II initiated 23 Apr 2015
    • Terminated Z-1890-2015 FDA Class II initiated 23 Apr 2015
    • Terminated Z-1908-2015 FDA Class II initiated 23 Apr 2015
    • Terminated Z-1898-2015 FDA Class II initiated 23 Apr 2015
    • Terminated Z-1907-2015 FDA Class II initiated 23 Apr 2015
    • Terminated Z-1889-2015 FDA Class II initiated 23 Apr 2015

    Catheters may not meet antimicrobial specification

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  • Withdrawn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
SESK Substantially Equivalent — Kit

Overview

AI-generated summary, 27 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 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome Sapphire) is a device intended for acute and chronic hemodialysis, apheresis, and infusion. It features a heparin coating and a silver-impregnated sleeve. The catheter may be inserted either percutaneously or by cutdown.

This device is supplied as a single-use item and is regulated under FDA 510(k) clearance with product code MSD. It is manufactured by Kendall and has a device class of 2. The catheter is designed for use in hemodialysis procedures and is available in the 14.5 Fr size.

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Questions

AI-generated answers, 27 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 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve used for?

    This catheter is intended for acute and chronic hemodialysis, apheresis, and infusion procedures. It can be inserted either percutaneously or by cutdown, providing flexibility in clinical applications.

  • Is the 14.5 Fr Chronic Hemodialysis Catheter reusable or single-use?

    The device is supplied as a single-use item, meaning it should be discarded after one use to ensure patient safety and maintain the integrity of the heparin coating and silver-impregnated sleeve.

  • What are the key features of the Palindrome Sapphire hemodialysis catheter?

    This catheter features a heparin coating to reduce thrombogenicity and a silver-impregnated sleeve to help minimize infection risk. It is available in the 14.5 French size and is designed for chronic hemodialysis procedures.

  • How is the 14.5 Fr Chronic Hemodialysis Catheter regulated?

    The device is regulated under FDA 510(k) clearance with product code MSD and has a device class of 2. This indicates it has been cleared by the FDA as a medical device with moderate risk.