ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000)— 510(k) K240447

Name: FDA 510(k) clearance K240447
Creator: U.S. Food and Drug Administration
Published: 2025-05-05

Unknown

Thermasolutions, LLC

FDA 510(k) clearance K240447 for ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000), Unknown on 2025-05-05. Applicant: Thermasolutions, LLC. Device class: 2.

Clearance details

Applicant: Thermasolutions, LLC
Product code: Code MLW
Device class: Class 2
Regulation: 21 CFR 876.5630
Advisory panel: Gastroenterology, Urology
Date received: 2024-02-15
Decision date: 2025-05-05
Decision: Unknown
Clearance type: Traditional
Location: White Bear Lake, MN, US

Download summary PDF View on FDA.gov ↗

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