Teleflex Isis HVT Tracheal Tube, Cuffed, with Subglottic Secretion Suction Port
FDA 510(k) K091761 · Teleflexmedical, Inc.
510(k) numberK091761
Submission
- Device name
- Teleflex Isis HVT Tracheal Tube, Cuffed, with Subglottic Secretion Suction Port
- Applicant
- Teleflexmedical, Inc.
Durham, NC, US - Received
- June 16, 2009
- Decision date
- October 29, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BTR – Tube, Tracheal (W/Wo Connector)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5730
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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| K253437 | Spiro-VISTABTR · Traditional | Spiro Robotics | 06/12/2026SE |
| K250173 | Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE Tracheal…BTR · Traditional | Covidien, LLC | 10/06/2025SE |
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| K243579 | AeroJet Ventilation CatheterBTR · Traditional | Pipeline Medical Products, LLC | 08/13/2025SE |
| K251499 | Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer…BTR · Special | William Cook Europe Aps | 06/11/2025SE |
| K250243 | ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu…BTR · Traditional | Flexicare Medical Limited. | 05/20/2025SE |
| K242495 | LMA Fastrach ETT SUBTR · Traditional | Teleflex Medical | 04/29/2025SE |
| K241451 | Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch…BTR · Traditional | Teleflex Incorporated | 02/11/2025SE |
| K233341 | Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440…BTR · Traditional | Covidien, LLC | 05/20/2024SE |
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Questions and answers
When was Teleflex Isis HVT Tracheal Tube, Cuffed, with Subglottic Secretion Suction Port cleared by the FDA?
Teleflex Isis HVT Tracheal Tube, Cuffed, with Subglottic Secretion Suction Port (K091761) received a 510(k) decision of Substantially Equivalent on October 29, 2009, 135 days after the submission was received.
What is the product code of K091761?
The FDA product code is BTR – Tube, Tracheal (W/Wo Connector), a Class II (moderate risk) device regulated under 21 CFR 868.5730.