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Crosspoint Transaccess Catheter, Model Ta-Xp-001

by Trans Vascular Incorporated

510(k) K031920

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 NumberK031920 Date23 Jul 2003ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0208-2007 FDA Unclassified (pre-2012) initiated 1 Nov 2006

    Sterility may be compromised as evidenced by a loss of package integrity.

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  • Withdrawn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
ITX
Device Class
Class II
Regulation
21 CFR Part 892.1570
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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