510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K000001Substantially Equivalent

Wallgraft Tracheobronchial Endoprosthesis and Unistep Delivery System

Boston Scientific Corporation, Plymouth MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000001 is the FDA 510(k) clearance record for WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM, a class II device, cleared for Boston Scientific Scimed, Inc. 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 K000001.

Clearance record

Decision date
Received
(154 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 Scimed, Inc. 5905 Nathan Ln., Plymouth MN
510(k) summary
Summary
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