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Integral Hemodialysis Catheter

by Arrow Int'L.

510(k) K040260

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

15 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 NumberK040260 Date5 Mar 2004ClearedStatusActive

Recalls

15 recalls · FDA

  • 15 recalls, same reason

    • Terminated Z-2275-2008 FDA Unclassified (pre-2012) initiated 10 Jun 2008
    • Terminated Z-2273-2008 FDA Unclassified (pre-2012) initiated 10 Jun 2008
    • Terminated Z-2276-2008 FDA Unclassified (pre-2012) initiated 10 Jun 2008
    • Terminated Z-2280-2008 FDA Unclassified (pre-2012) initiated 10 Jun 2008
    • Terminated Z-2279-2008 FDA Unclassified (pre-2012) initiated 10 Jun 2008
    • Terminated Z-2271-2008 FDA Unclassified (pre-2012) initiated 10 Jun 2008
    • Terminated Z-2281-2008 FDA Unclassified (pre-2012) initiated 10 Jun 2008
    • Terminated Z-2277-2008 FDA Unclassified (pre-2012) initiated 10 Jun 2008
    • Terminated Z-2285-2008 FDA Unclassified (pre-2012) initiated 10 Jun 2008
    • Terminated Z-2284-2008 FDA Unclassified (pre-2012) initiated 10 Jun 2008
    • Terminated Z-2272-2008 FDA Unclassified (pre-2012) initiated 10 Jun 2008
    • Terminated Z-2274-2008 FDA Unclassified (pre-2012) initiated 10 Jun 2008
    • Terminated Z-2278-2008 FDA Unclassified (pre-2012) initiated 10 Jun 2008
    • Terminated Z-2283-2008 FDA Unclassified (pre-2012) initiated 10 Jun 2008
    • Terminated Z-2282-2008 FDA Unclassified (pre-2012) initiated 10 Jun 2008

    The tips may not have been adequately welded to the catheter body.

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  • Withdrawn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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