510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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CBIClass II

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

21 CFR 868.5740 / Anesthesiology
FDA source (opens on fda.gov)

CBI is the FDA product code for Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector), a class II device type, regulated under 21 CFR 868.5740. As of , FDA records hold 34 510(k) clearances under this code, the most recent dated , and 10 recalls.

Classification record

Product code
CBI
Device name
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Regulation
21 CFR 868.5740
Device class
Class II
Review panel
Anesthesiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
34
Ingested recalls
10

Clearances, product code CBI

By decision year
34 clearances under product code CBI with a decision year between 1985 and 2026, 2012 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code CBI by decision year
YearClearances
19851
19891
19901
19931
19951
19961
19971
20001
20011
20022
20051
20081
20091
20102
20111
20123
20131
20151
20162
20182
20201
20212
20221
20231
20241
20262

Applicants with the most clearances

Product code CBI
Applicants holding the most 510(k) clearances under product code CBI
ApplicantClearances
Cook Inc.4
Etview, Ltd.4
PULMONX, Corp.4
Daiken Medical Co, Ltd.2
Shenzhen Insighters Medical Technology Co., Ltd.2
Sheridan Catheter Corp.2
Ambu A/S1
Cook Incorporated1
Ez-Blocker B.V.1
Fuji Systems Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 30 companies shown, in name order