510(k) K240447
- Device
- ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000)
- Applicant
- Thermasolutions, LLC
- 510(k) number
- K240447
- Product code
- MLW
- Decision
- Unknown (SESK)
- Decision date
- 2025-05-05
- Date received
- 2024-02-15
- Regulation
- 876.5630
- Classification name
- Warmer, Peritoneal Dialysate
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Rhea Johny
- Address
- 1889 Buerkle Rd. White Bear Lake MN US 55110 55110
FDA Registration Numbers#
- 3005699784
- 3012706378
- 3014377913
- 3006986257
- 3003661577
Source Documents#
Other 510(k) Records For Product Code MLW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K131583 | THERMOCHEM HT-2000 | Thermasolutions, Inc. | 2013-10-03 |
| K020542 | DAYTRIPPER DIALYSATE WARMER | Stickman Industries, Inc. | 2002-09-27 |
| K993330 | THERMOCHEM-HT SYSTEM | Hemocleanse, Inc. | 1999-12-30 |
| K964825 | FREEDOM TRAVELLER | Impact Case Technologies, Inc. | 1997-05-19 |
| K933619 | PD-PAK | General Medical Mfg. Co. | 1994-02-22 |