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Vaxcel Picc with Pasv Valve Technology

by Catheter Innovations, Inc.

510(k) K021704

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

31 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 NumberK021704 Date6 Jun 2002ClearedStatusActive

Recalls

31 recalls · FDA

  • 23 recalls, same reason

    • Terminated Z-1985-2016 FDA Class II initiated 14 Mar 2016
    • Terminated Z-1980-2016 FDA Class II initiated 14 Mar 2016
    • Terminated Z-1984-2016 FDA Class II initiated 14 Mar 2016
    • Terminated Z-1966-2016 FDA Class II initiated 14 Mar 2016
    • Terminated Z-1982-2016 FDA Class II initiated 14 Mar 2016
    • Terminated Z-1974-2016 FDA Class II initiated 14 Mar 2016
    • Terminated Z-1972-2016 FDA Class II initiated 14 Mar 2016
    • Terminated Z-1969-2016 FDA Class II initiated 14 Mar 2016
    • Terminated Z-1971-2016 FDA Class II initiated 14 Mar 2016
    • Terminated Z-1988-2016 FDA Class II initiated 14 Mar 2016
    • Terminated Z-1977-2016 FDA Class II initiated 14 Mar 2016
    • Terminated Z-1975-2016 FDA Class II initiated 14 Mar 2016
    • Terminated Z-1987-2016 FDA Class II initiated 14 Mar 2016
    • Terminated Z-1973-2016 FDA Class II initiated 14 Mar 2016
    • Terminated Z-1976-2016 FDA Class II initiated 14 Mar 2016
    • Terminated Z-1986-2016 FDA Class II initiated 14 Mar 2016
    • Terminated Z-1979-2016 FDA Class II initiated 14 Mar 2016
    • Terminated Z-1970-2016 FDA Class II initiated 14 Mar 2016
    • Terminated Z-1967-2016 FDA Class II initiated 14 Mar 2016
    • Terminated Z-1978-2016 FDA Class II initiated 14 Mar 2016
    • Terminated Z-1968-2016 FDA Class II initiated 14 Mar 2016
    • Terminated Z-1981-2016 FDA Class II initiated 14 Mar 2016
    • Terminated Z-1983-2016 FDA Class II initiated 14 Mar 2016

    PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.

  • 8 recalls, same reason

    • Terminated Z-0406-05 FDA Unclassified (pre-2012) initiated 22 Nov 2004
    • Terminated Z-0409-05 FDA Unclassified (pre-2012) initiated 22 Nov 2004
    • Terminated Z-0407-05 FDA Unclassified (pre-2012) initiated 22 Nov 2004
    • Terminated Z-0410-05 FDA Unclassified (pre-2012) initiated 22 Nov 2004
    • Terminated Z-0405-05 FDA Unclassified (pre-2012) initiated 22 Nov 2004
    • Terminated Z-0404-05 FDA Unclassified (pre-2012) initiated 22 Nov 2004
    • Terminated Z-0403-05 FDA Unclassified (pre-2012) initiated 22 Nov 2004
    • Terminated Z-0408-05 FDA Unclassified (pre-2012) initiated 22 Nov 2004

    Catheter separation immediately distal to the nose of the suture wing.

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
LJS
Device Class
Class II
Regulation
21 CFR Part 880.5970
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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