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

Prosthesis, Tracheal, Expandable

21 CFR 878.3720 / General, Plastic Surgery
FDA source (opens on fda.gov)

JCT is the FDA product code for Prosthesis, Tracheal, Expandable, a class II device type, regulated under 21 CFR 878.3720. As of , FDA records hold 45 510(k) clearances under this code, the most recent dated , and 61 recalls.

Classification record

Product code
JCT
Device name
Prosthesis, Tracheal, Expandable
Regulation
21 CFR 878.3720
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
45
Ingested recalls
61

Clearances, product code JCT

By decision year
45 clearances under product code JCT with a decision year between 1991 and 2023, 2003 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code JCT by decision year
YearClearances
19911
19941
19951
19964
19982
19992
20003
20011
20024
20036
20043
20052
20072
20081
20091
20121
20143
20161
20181
20201
20212
20221
20231

Applicants with the most clearances

Product code JCT
Applicants holding the most 510(k) clearances under product code JCT
ApplicantClearances
Boston Scientific Corporation17
Alveolus, Inc.8
Micro-Tech (Nanjing) Co., Ltd.3
Vascular Architects, Inc.3
W. L. Gore & Associates, Inc.3
Atrium Medical Corporation2
Bard Peripheral Vascular Inc2
Intratherapeutics, Inc.2
Merit Medical Systems, Inc.2
Cook Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 21 companies shown, in name order