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Crossover

by Thomas Medical Products, Inc.

510(k) K083269

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 · Traditional NumberK083269 Date3 Feb 2009ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0120-2010 FDA Unclassified (pre-2012) initiated 21 Oct 2009

    Sheath may break or fracture which may cause vessel damage or require surgical intervention to retrieve catheter pieces.

    • Terminated Z-0087-2010 FDA Unclassified (pre-2012) initiated 15 Oct 2009

    Cordis has received complaints of stretching or fracture of the sheath shaft during use.

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  • Withdrawn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
DYB
Device Class
Class II
Regulation
21 CFR Part 870.1340
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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