Medsource Endotracheal Tube (with and Without Cuff)
FDA 510(k) K080339 · Medsource International, LLC
510(k) numberK080339
Submission
- Device name
- Medsource Endotracheal Tube (with and Without Cuff)
- Applicant
- Medsource International, LLC
Indianapolis, IN, US - Received
- February 8, 2008
- Decision date
- October 27, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
Other 510(k)s with product code BTR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251794 | Tenax® Laser Resistant Endotracheal TubeBTR · Traditional | Bryan Medical, Inc. | 09/03/2026SE |
| 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 |
| K243785 | Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley…BTR · Traditional | Covidien, LLC | 09/25/2025SE |
| 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 |
More from Covidien, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K223788 | The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe…FOZ · Traditional | 09/15/2023SE |
| K161779 | MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV CatheterFOZ · Traditional | 11/03/2016SE |
| K150611 | MedSource ClearSafe Safety IV CatheterFOZ · Traditional | 07/15/2015SE |
| K150333 | MedSource Sharps DartMMK · Traditional | 05/08/2015SE |
| K140442 | Medsource Selectable IV SetLHI · Special | 04/22/2014SE |
| K140402 | Medsource IV Administration Set 72 Medsource IV Administration Set, Needleless Male…LHI · Special | 04/03/2014SE |
| K131555 | Medsource IV Safety CatheterFOZ · Traditional | 01/31/2014SE |
| K120424 | Medsource IV Adminstration SetLHI · Traditional | 07/11/2012SE |
| K081516 | Medsource CPR Mask with & Without Oxygen PortCBP · Traditional | 08/26/2008SE |
Questions and answers
When was Medsource Endotracheal Tube (with and Without Cuff) cleared by the FDA?
Medsource Endotracheal Tube (with and Without Cuff) (K080339) received a 510(k) decision of Substantially Equivalent on October 27, 2008, 262 days after the submission was received.
What is the product code of K080339?
The FDA product code is BTR – Tube, Tracheal (W/Wo Connector), a Class II (moderate risk) device regulated under 21 CFR 868.5730.