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510(k) K240447

ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) by Thermasolutions, LLC — Product Code MLW

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
May 5, 2025
Date Received
February 15, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Warmer, Peritoneal Dialysate
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

Other clearances by Thermasolutions, LLC

  • K222575 — HurriChem Device Kit (December 6, 2022)
  • K131583 — THERMOCHEM HT-2000 (October 3, 2013)

Other clearances for product code MLW

  • K131583 — THERMOCHEM HT-2000 (October 3, 2013)
  • K020542 — DAYTRIPPER DIALYSATE WARMER (September 27, 2002)
  • K993330 — THERMOCHEM-HT SYSTEM (December 30, 1999)
  • K964825 — FREEDOM TRAVELLER (May 19, 1997)
  • K933619 — PD-PAK (February 22, 1994)