Sheridan Endobronchial Tubes
FDA 510(k) K180253 · Teleflex Medical
510(k) numberK180253
Submission
- Device name
- Sheridan Endobronchial Tubes
- Applicant
- Teleflex Medical
Morrisville, NC, US - Received
- January 30, 2018
- Decision date
- November 2, 2018
- 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
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|---|---|---|---|
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| K232529 | Disposable Double Lumen Endobronchial TubeCBI · Traditional | Shenzhen Insighters Medical Technology Co., Ltd. | 05/13/2024SE |
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| K222340 | Chartis Precision CatheterCBI · Traditional | Pulmonx Corporation | 12/01/2022SE |
| K201026 | sOLVe TubeCBI · Traditional | Hytek Medical, Inc. | 08/10/2021SE |
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| 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 |
| K160542 | 5.0 Fr Arndt Endobronchial Blocker SetCBI · Special | Cook Incorporated | 08/02/2016SE |
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Questions and answers
When was Sheridan Endobronchial Tubes cleared by the FDA?
Sheridan Endobronchial Tubes (K180253) received a 510(k) decision of Substantially Equivalent on November 2, 2018, 276 days after the submission was received.
What is the product code of K180253?
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.