510(k) K240447
K240447 is an FDA 510(k) premarket notification submitted by Thermasolutions, LLC for the device "ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000)". The FDA issued a decision of Substantially Equivalent (kit) on May 5, 2025. The device falls under product code MLW (Warmer, Peritoneal Dialysate), a Class II device regulated under 21 CFR 876.5630. Thermasolutions, LLC has at least 2 other 510(k) clearances on record.
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