510(k) K092886
- Device
- WELL LEAD ENDOBRONCHIAL TUBES
- Applicant
- WELL LEAD INSTRUMENTS
- 510(k) number
- K092886
- Product code
- CBI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-03-11
- Date received
- 2009-09-21
- Regulation
- 868.5740
- Classification name
- Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector)
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ARTHUR WARD
- Address
- 962 Allegro Ln. Apollo Beach FL US 33570 33570
FDA Registration Numbers#
- 3006984712
- 3004040397
- 3007134520
- 3011137372
- 9617604
- 3005609751
- 2936999
- 2011171
- 1423662
- 3012307300
- 1000563940
- 3009171251
- 9610691
- 3004784537
- 3003898360
- 3010131137
- 3014656749
- 1314417
- 3009093866
- 3004111573
- 3018094310
- 2032112
- 3010400865
- 8040412
- 1820334
- 3006017180
- 3013528571
- 9681384
- 3010220595
- 3006425876
- 3013023209
- 3004748541
- 3012050423
- 3007797756
- 3000308637
Source Documents#
Other 510(k) Records For Product Code CBI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251950 | 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) | Hangzhou Tappa Medical Technology Co., Ltd. | 2026-03-20 |
| K253096 | Chartis Precision Catheter | Pulmonx Corporation | 2026-02-13 |
| K232529 | Disposable Double Lumen Endobronchial Tube | Shenzhen Insighters Medical Technology Co., Ltd. | 2024-05-13 |
| K232580 | Disposable Endobronchial Blocker Tube | Shenzhen Insighters Medical Technology Co., Ltd. | 2023-12-14 |
| K222340 | Chartis Precision Catheter | Pulmonx Corporation | 2022-12-01 |
| K201026 | sOLVe Tube | Hytek Medical, Inc. | 2021-08-10 |
| K203749 | Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable | Ambu A/S | 2021-05-03 |
| K200968 | ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R | Insung Medical Co., Ltd. | 2020-12-28 |
| K181886 | VivaSight-DL System | Etview , Ltd. | 2018-11-14 |
| K180253 | Sheridan Endobronchial Tubes | Teleflex Medical | 2018-11-02 |
| K160542 | 5.0 Fr Arndt Endobronchial Blocker Set | Cook Incorporated | 2016-08-02 |
| K152251 | Endobronchial Tube | Henan Tuoren Medical Device Co., Ltd. | 2016-06-10 |
| K141888 | RUSCH ENDOBRONCHIAL TUBES | Teleflexmedical, Inc. | 2015-04-15 |
| K123853 | VIVASIGHT-DL SYSTEM | Etview , Ltd. | 2013-04-15 |
| K121462 | EZ-BLOCKER | Ez-Blocker B.V. | 2012-09-28 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases