Rusch Endobronchial Tubes
FDA 510(k) K141888 · Teleflexmedical, Inc.
510(k) numberK141888
Submission
- Device name
- Rusch Endobronchial Tubes
- Applicant
- Teleflexmedical, Inc.
Durham, NC, US - Received
- July 14, 2014
- Decision date
- April 15, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CBI – Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5740
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
Other 510(k)s with product code CBI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251950 | Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107)…CBI · Traditional | Hangzhou Tappa Medical Technology Co., Ltd. | 03/20/2026SE |
| K253096 | Chartis Precision CatheterCBI · Traditional | Pulmonx Corporation | 02/13/2026SE |
| K232529 | Disposable Double Lumen Endobronchial TubeCBI · Traditional | Shenzhen Insighters Medical Technology Co., Ltd. | 05/13/2024SE |
| K232580 | Disposable Endobronchial Blocker TubeCBI · Traditional | Shenzhen Insighters Medical Technology Co., Ltd. | 12/14/2023SE |
| K222340 | Chartis Precision CatheterCBI · Traditional | Pulmonx Corporation | 12/01/2022SE |
| K201026 | sOLVe TubeCBI · Traditional | Hytek Medical, Inc. | 08/10/2021SE |
| K203749 | Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter CableCBI · Traditional | Ambu A/S | 05/03/2021SE |
| K200968 | ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39RCBI · Traditional | Insung Medical Co., Ltd. | 12/28/2020SE |
| K181886 | VivaSight-DL SystemCBI · Special | Etview , Ltd. | 11/14/2018SE |
| K180253 | Sheridan Endobronchial TubesCBI · Traditional | Teleflex Medical | 11/02/2018SE |
More from Teleflex Medical
| 510(k) | Device | Decision |
|---|---|---|
| K232469 | Rüsch Latex Gold Foley CatheterEZL · Traditional | 08/01/2024SE |
| K212077 | Teleflex Rusch SoftSimplastic Foley CathetersEZL · Traditional | 07/27/2023SE |
| K192324 | Sheridan Spiral-Flex Endotracheal TubesBTR · Traditional | 12/06/2019SE |
| K182847 | Hudson RCI Voldyne Volumetric ExerciserBWF · Traditional | 07/01/2019SE |
| K181979 | Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterKOD · Traditional | 05/24/2019SE |
| K183461 | Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent…GBM · Traditional | 05/08/2019SESK |
| K181852 | Percuvance Percutaneous Surgical SystemGEI · Traditional | 10/12/2018SE |
| K173280 | Neonatal ConchaSmart Breathing CircuitsBZE · Traditional | 08/02/2018SE |
| K172775 | MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip HandleOCW · Traditional | 02/12/2018SE |
| K161770 | Rusch Silicone Foley CatheterEZL · Traditional | 05/05/2017SE |
Questions and answers
When was Rusch Endobronchial Tubes cleared by the FDA?
Rusch Endobronchial Tubes (K141888) received a 510(k) decision of Substantially Equivalent on April 15, 2015, 275 days after the submission was received.
What is the product code of K141888?
The FDA product code is CBI – Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector), a Class II (moderate risk) device regulated under 21 CFR 868.5740.