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Alta Lr Fixed Tip Chronic Hemodialysis Catheter, Models AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40

by Spire Biomedical, Inc.

510(k) K040509

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

48 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 · Special NumberK040509 Date19 Apr 2004ClearedStatusActive

Recalls

48 recalls · FDA

  • 48 recalls, same reason

    • Terminated Z-0331-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0335-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0304-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0292-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0324-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0314-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0329-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0334-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0307-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0298-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0300-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0333-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0289-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0327-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0312-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0297-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0301-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0322-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0323-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0293-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0321-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0317-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0310-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0302-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0325-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0295-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0291-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0303-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0315-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0313-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0318-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0290-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0294-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0326-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0305-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0288-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0332-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0320-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0299-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0296-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0328-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0319-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0316-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0330-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0309-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0308-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0306-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009
    • Terminated Z-0311-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009

    There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira

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
SESE Substantially Equivalent

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