FDA Product Code
FDA Product Code MLW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5630
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K240447 | ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) | Thermasolutions, LLC | 2025-05-05 | Traditional | PDF ↗ |
| K131583 | THERMOCHEM HT-2000 | Thermasolutions, Inc. | 2013-10-03 | Traditional | PDF ↗ |
| K020542 | DAYTRIPPER DIALYSATE WARMER | Stickman Industries, Inc. | 2002-09-27 | Traditional | PDF ↗ |
| K993330 | THERMOCHEM-HT SYSTEM | Hemocleanse, Inc. | 1999-12-30 | Traditional | PDF ↗ |
| K964825 | FREEDOM TRAVELLER | Impact Case Technologies, Inc. | 1997-05-19 | Traditional | PDF ↗ |
| K933619 | PD-PAK | General Medical Mfg. Co. | 1994-02-22 | Traditional | PDF ↗ |
Product code MLW · Class II · Gastroenterology, Urology. Data: openFDA.