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Trach-Eze Closed Ventilation Suction System

by Sorenson Critical Care

510(k) K961707

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 · Traditional NumberK961707 Date11 Mar 1997ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0496-03 FDA Unclassified (pre-2012) initiated 25 Nov 2002

    Catheters have 2 unvalidated seal product configurations to produce a new hybrid seal that had not been verified or validated.

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  • Withdrawn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
BSY
Device Class
Class I
Regulation
21 CFR Part 868.6810
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent