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FDA 510(k)

ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000)

K-Number: K240447 · 2025-05-05

ApplicantThermasolutions, LLC
Decision Date2025-05-05
Product CodeMLW
Advisory CommitteeGU
DecisionUnknown

Device Summary

ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) is a medical device manufactured by Thermasolutions, LLC. It received FDA 510(k) clearance on 2025-05-05 under approval number K240447. The device is classified under product code MLW. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000)?

ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) is a medical device that received FDA 510(k) clearance on 2025-05-05. It is manufactured by Thermasolutions, LLC. The 510(k) number is K240447.

When was ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) approved by the FDA?

ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) received FDA 510(k) clearance on 2025-05-05, under approval number K240447.

What company makes ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000)?

ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) is manufactured by Thermasolutions, LLC.

What is the FDA product code for ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000)?

The FDA product code for ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) is MLW.

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Related PubMed Literature

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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