| Device Classification Name |
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
|
|---|
| 510(k) Number |
K251950 |
|---|
| Device Name |
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) |
|---|
| Applicant |
| Hangzhou Tappa Medical Technology Co., Ltd. |
| #225, Chutian Rd., Binjiang District |
|
Hangzhou,
CN
310000
|
|
| Applicant Contact |
Kaixiu Peng |
| Correspondent |
| Hangzhou Tappa Medical Technology Co., Ltd. |
| #225, Chutian Rd., Binjiang District |
|
Hangzhou,
CN
310000
|
|
| Correspondent Contact |
Kaixiu Peng |
| Regulation Number | 868.5740 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 06/25/2025 |
|---|
| Decision Date | 03/20/2026 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Anesthesiology
|
|---|
| 510k Review Panel |
Anesthesiology
|
|---|
| Summary |
Summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|
|
|
