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

Tube, Bronchial (W/Wo Connector)

21 CFR 868.5720 / Anesthesiology
FDA source (opens on fda.gov)

BTS is the FDA product code for Tube, Bronchial (W/Wo Connector), a class II device type, regulated under 21 CFR 868.5720. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and 11 recalls.

Classification record

Product code
BTS
Device name
Tube, Bronchial (W/Wo Connector)
Regulation
21 CFR 868.5720
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
6
Ingested recalls
11

Clearances, product code BTS

By decision year
6 clearances under product code BTS with a decision year between 1977 and 1995, 1995 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code BTS by decision year
YearClearances
19771
19831
19841
19901
19952

Applicants with the most clearances

Product code BTS
Applicants holding the most 510(k) clearances under product code BTS
ApplicantClearances
Concord/Portex1
Mallinckrodt Critical Care1
Abbott Medical1
Rusch Intl.1
Rusch, Inc.1
Surgitek1

Companies listing this code with FDA

Companies whose registered establishments list this code