Bronchial Blocker
FDA 510(k) K962167 · Cook, Inc.
510(k) numberK962167
Submission
- Device name
- Bronchial Blocker
- Applicant
- Cook, Inc.
Bloomington, IN, US - Received
- June 5, 1996
- Decision date
- August 29, 1997
- 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
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|---|---|---|---|
| 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 |
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Questions and answers
When was Bronchial Blocker cleared by the FDA?
Bronchial Blocker (K962167) received a 510(k) decision of Substantially Equivalent on August 29, 1997, 450 days after the submission was received.
What is the product code of K962167?
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.