510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K110407Substantially Equivalent

Invisiport

Stealth Therapeutics, Incorporated, Stoughton WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K110407 is the FDA 510(k) clearance record for INVISIPORT, a class II device, cleared for Stealth Therapeutics, Incorporated on under FDA product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular). FDA records list 2 510(k) clearances for Stealth Therapeutics, Incorporated, from to . As of , FDA records show no recalls naming K110407.

Clearance record

Decision date
Received
(241 days to decision)
Product code
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Regulation
21 CFR 880.5965
Device class
Class II
Review panel
General Hospital
Applicant
Stealth Therapeutics, Incorporated 800 Levanger Ln., Stoughton WI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LJT

Trailing 12 months
1 clearance under product code LJT in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LJT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260