510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K021901Substantially Equivalent

Wallgraft Tracheobronchial Endoprothesis with Unistep Plus Delivery System

Boston Scientific Corporation, Maple Grove MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021901 is the FDA 510(k) clearance record for WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS 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 K021901.

Clearance record

Decision date
Received
(29 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. One Scimed Pl., Maple Grove MN
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