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Palindrome Emerald 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating

by Tyco Healthcare Group

510(k) K060509

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK060509 Date23 Jun 2006ClearedStatusActive

Recalls

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-0409-2009 FDA Unclassified (pre-2012) initiated 19 Sep 2008
    • Terminated Z-0411-2009 FDA Unclassified (pre-2012) initiated 19 Sep 2008
    • Terminated Z-0408-2009 FDA Unclassified (pre-2012) initiated 19 Sep 2008
    • Terminated Z-0410-2009 FDA Unclassified (pre-2012) initiated 19 Sep 2008

    Incorrect size of the Venetrac stylets (an optional accessory). They are too short and cannot be used.

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  • Withdrawn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

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