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Kedall 14.5 Fr Chronic Hemodialysis Catheter W/Silver Impregnated Sleeve (Palindrome Ruby)

by Kendall

510(k) K060972

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

38 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 NumberK060972 Date4 Aug 2006ClearedStatusActive

Recalls

38 recalls · FDA

  • 38 recalls, same reason

    • Terminated Z-1880-2015 FDA Class II initiated 23 Apr 2015
    • Terminated Z-1863-2015 FDA Class II initiated 23 Apr 2015 on shared 510(k) K060972
    • Terminated Z-1883-2015 FDA Class II initiated 23 Apr 2015 on shared 510(k) K060972
    • Terminated Z-1879-2015 FDA Class II initiated 23 Apr 2015
    • Terminated Z-1874-2015 FDA Class II initiated 23 Apr 2015
    • Terminated Z-1862-2015 FDA Class II initiated 23 Apr 2015 on shared 510(k) K060972
    • Terminated Z-1850-2015 FDA Class II initiated 23 Apr 2015 on shared 510(k) K060972
    • Terminated Z-1875-2015 FDA Class II initiated 23 Apr 2015
    • Terminated Z-1872-2015 FDA Class II initiated 23 Apr 2015
    • Terminated Z-1873-2015 FDA Class II initiated 23 Apr 2015
    • Terminated Z-1851-2015 FDA Class II initiated 23 Apr 2015 on shared 510(k) K060972
    • Terminated Z-1882-2015 FDA Class II initiated 23 Apr 2015 on shared 510(k) K060972
    • Terminated Z-1866-2015 FDA Class II initiated 23 Apr 2015 on shared 510(k) K060972
    • Terminated Z1856-2015 FDA Class II initiated 23 Apr 2015 on shared 510(k) K060972
    • Terminated Z-1858-2015 FDA Class II initiated 23 Apr 2015 on shared 510(k) K060972
    • Terminated Z1855-2015 FDA Class II initiated 23 Apr 2015 on shared 510(k) K060972
    • Terminated Z-1853-2015 FDA Class II initiated 23 Apr 2015 on shared 510(k) K060972
    • Terminated Z-1859-2015 FDA Class II initiated 23 Apr 2015 on shared 510(k) K060972
    • Terminated Z-1878-2015 FDA Class II initiated 23 Apr 2015
    • Terminated Z-1884-2015 FDA Class II initiated 23 Apr 2015
    • Terminated Z-1870-2015 FDA Class II initiated 23 Apr 2015
    • Terminated Z-1861-2015 FDA Class II initiated 23 Apr 2015 on shared 510(k) K060972
    • Terminated Z-1860-2015 FDA Class II initiated 23 Apr 2015 on shared 510(k) K060972
    • Terminated Z-1857-2015 FDA Class II initiated 23 Apr 2015 on shared 510(k) K060972
    • Terminated Z-1864-2015 FDA Class II initiated 23 Apr 2015 on shared 510(k) K060972
    • Terminated Z-1854-2015 FDA Class II initiated 23 Apr 2015 on shared 510(k) K060972
    • Terminated Z-1881-2015 FDA Class II initiated 23 Apr 2015 on shared 510(k) K060972
    • Terminated Z-1869-2015 FDA Class II initiated 23 Apr 2015
    • Terminated Z-1887-2015 FDA Class II initiated 23 Apr 2015
    • Terminated Z-1865-2015 FDA Class II initiated 23 Apr 2015 on shared 510(k) K060972
    • Terminated Z-1886-2015 FDA Class II initiated 23 Apr 2015
    • Terminated Z-1852-2015 FDA Class II initiated 23 Apr 2015 on shared 510(k) K060972
    • Terminated Z-1871-2015 FDA Class II initiated 23 Apr 2015
    • Terminated Z-1867-2015 FDA Class II initiated 23 Apr 2015 on shared 510(k) K060972
    • Terminated Z-1877-2015 FDA Class II initiated 23 Apr 2015
    • Terminated Z-1876-2015 FDA Class II initiated 23 Apr 2015
    • Terminated Z-1885-2015 FDA Class II initiated 23 Apr 2015
    • Terminated Z-1868-2015 FDA Class II initiated 23 Apr 2015

    Catheters may not meet antimicrobial specification

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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

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