510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K141584Substantially Equivalent

Ultraflex Tracheobronchial Covered Stent System

Boston Scientific Corporation, Marlboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K141584 is the FDA 510(k) clearance record for ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM, a class II device, cleared for Boston Scientific Corporation on under FDA product code JCT (Prosthesis, Tracheal, Expandable). FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show one recall naming K141584.

Clearance record

Decision date
Received
(125 days to decision)
Product code
JCT Prosthesis, Tracheal, Expandable
Regulation
21 CFR 878.3720
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Boston Scientific Corporation 100 Boston Scientific Way, Marlboro MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JCT

Trailing 12 months

FDA records hold no clearances under product code JCT in the trailing twelve months.

FDA records show no clearances under product code JCT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JCT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260