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MLW — Warmer, Peritoneal Dialysate Class II

FDA Device Classification

Classification Details

Product Code
MLW
Device Class
Class II
Regulation Number
876.5630
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K240447thermasolutionsThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (May 5, 2025
K131583thermasolutionsTHERMOCHEM HT-2000October 3, 2013
K020542stickman industriesDAYTRIPPER DIALYSATE WARMERSeptember 27, 2002
K993330hemocleanseTHERMOCHEM-HT SYSTEMDecember 30, 1999
K964825impact case technologiesFREEDOM TRAVELLERMay 19, 1997
K933619general medical mfgPD-PAKFebruary 22, 1994