Chrysalis Intelligence · Product Codes · CBI

CBI · Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)

Anesthesiology · 8 clearances · 6 unique sponsors

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Device class

Class II

Regulation 868.5740

Total clearances

8

2020-12-28 → 2026-03-20

Last 12 months

2

Unique sponsors

6

Classification details

Medical specialty

Anesthesiology

Review panel

AN

Regulation number

868.5740

Implant

N

Life-sustain / support

Y

GMP exempt

N

Third-party review

N

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Pulmonx Corporation	2	1	2026-02-13
Shenzhen Insighters Medical Technology Co., Ltd.	2	0	2024-05-13
Ambu A/S	1	0	2021-05-03
Hytek Medical, Inc.	1	0	2021-08-10
Insung Medical Co., Ltd.	1	0	2020-12-28
Hangzhou Tappa Medical Technology Co., Ltd.	1	1	2026-03-20

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-03-20	K251950	Hangzhou Tappa Medical Technology Co., Ltd.	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)
2026-02-13	K253096	Pulmonx Corporation	Chartis Precision Catheter
2024-05-13	K232529	Shenzhen Insighters Medical Technology Co., Ltd.	Disposable Double Lumen Endobronchial Tube
2023-12-14	K232580	Shenzhen Insighters Medical Technology Co., Ltd.	Disposable Endobronchial Blocker Tube
2022-12-01	K222340	Pulmonx Corporation	Chartis Precision Catheter
2021-08-10	K201026	Hytek Medical, Inc.	sOLVe Tube
2021-05-03	K203749	Ambu A/S	Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable
2020-12-28	K200968	Insung Medical Co., Ltd.	ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R