Teleflex Isis Hvt Tracheal Tube, Cuffed, with Subglottic Secretion Suction Port

510(k) K091761

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

15 closed

Documents

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Abbreviated	NumberK091761	Date29 Oct 2009Cleared	StatusActive

15 recalls · FDA

- Terminated Z-1956-2019 FDA Class I initiated 7 Jun 2019
Centurion is conducting a sub-recall for Teleflex Sheridan branded Endotracheal Tracheal Tubes due to increased incidence of Sheridan connector becoming disconnected from Endotracheal Tube.
14 recalls, same reason
- Terminated Z-0960-2014 FDA Class I initiated 6 Jan 2014
- Terminated Z-0958-2014 FDA Class I initiated 6 Jan 2014
- Terminated Z-0959-2014 FDA Class I initiated 6 Jan 2014
- Terminated Z-0951-2014 FDA Class I initiated 6 Jan 2014
- Terminated Z-0954-2014 FDA Class I initiated 6 Jan 2014
- Terminated Z-0952-2014 FDA Class I initiated 6 Jan 2014
- Terminated Z-0961-2014 FDA Class I initiated 6 Jan 2014
- Terminated Z-0953-2014 FDA Class I initiated 6 Jan 2014
- Terminated Z-0962-2014 FDA Class I initiated 6 Jan 2014
- Terminated Z-0950-2014 FDA Class I initiated 6 Jan 2014
- Terminated Z-0963-2014 FDA Class I initiated 6 Jan 2014
- Terminated Z-0956-2014 FDA Class I initiated 6 Jan 2014
- Terminated Z-0955-2014 FDA Class I initiated 6 Jan 2014
- Terminated Z-0957-2014 FDA Class I initiated 6 Jan 2014
The tracheal tube can kink during patient use.

1 jurisdiction

United States — FDA 510(k) Active

510(k)