UNIVENT TUBE 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MM
FDA 510(k) clearance K894337 · decided 1989-09-29
Clearance details
- K-number
- K894337
- Device name
- UNIVENT TUBE 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MM
- Applicant
- Vitaid, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1989-07-14
- Decision date
- 1989-09-29
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- CBI
- Device class
- 2
- Regulation number
- 868.5740
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Ontario, Canada, CA
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobronchial Blocker Tube (EBT0109S); Endobronchial Blocker Tube (EBT0107S); Endobronchial Blocker Tube (EBT0105S); Endobronchial Blocker Tube (EBT0209); Endobronchial Blocker Tube (EBT0207); Endobronchial Blocker Tube (EBT0205); Endobronchial Blocker Tube (EBT0209S); Endobronchial Blocker Tube (EBT0207S); Endobronchial Blocker Tube (EBT0205S) (K251950) | Hangzhou Tappa Medical Technology Co., Ltd. | 2026-03-20 |
| Chartis Precision Catheter (K253096) | Pulmonx Corporation | 2026-02-13 |
| Disposable Double Lumen Endobronchial Tube (K232529) | Shenzhen Insighters Medical Technology Co., Ltd. | 2024-05-13 |
| Disposable Endobronchial Blocker Tube (K232580) | Shenzhen Insighters Medical Technology Co., Ltd. | 2023-12-14 |
| Chartis Precision Catheter (K222340) | Pulmonx Corporation | 2022-12-01 |
| sOLVe Tube (K201026) | Hytek Medical, Inc. | 2021-08-10 |
| Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable (K203749) | Ambu A/S | 2021-05-03 |
| ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R (K200968) | Insung Medical Co., Ltd. | 2020-12-28 |
| VivaSight-DL System (K181886) | Etview , Ltd. | 2018-11-14 |
| Sheridan Endobronchial Tubes (K180253) | Teleflex Medical | 2018-11-02 |
| 5.0 Fr Arndt Endobronchial Blocker Set (K160542) | Cook Incorporated | 2016-08-02 |
| Endobronchial Tube (K152251) | Henan Tuoren Medical Device Co., Ltd. | 2016-06-10 |
Recalls involving this device
No recalls on record reference this clearance.