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510(k) K993330

THERMOCHEM-HT SYSTEM by Hemocleanse, Inc. — Product Code MLW

K993330 is an FDA 510(k) premarket notification submitted by Hemocleanse, Inc. for the device "THERMOCHEM-HT SYSTEM". The FDA issued a decision of Substantially Equivalent on December 30, 1999. The device falls under product code MLW (Warmer, Peritoneal Dialysate), a Class II device regulated under 21 CFR 876.5630. Hemocleanse, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1999
Date Received
October 4, 1999
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 Hemocleanse, Inc.

  • K992196 — BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK) (September 10, 1999)
  • K984546 — BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000- (August 13, 1999)
  • K953751 — BIOLOGIC-DT SYSTEM (February 15, 1996)
  • K923046 — BIOLOGIC DT-1000 MACHINE (September 30, 1994)

Other clearances for product code MLW

  • K240447 — ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit ( (May 5, 2025)
  • K131583 — THERMOCHEM HT-2000 (October 3, 2013)
  • K020542 — DAYTRIPPER DIALYSATE WARMER (September 27, 2002)
  • K964825 — FREEDOM TRAVELLER (May 19, 1997)
  • K933619 — PD-PAK (February 22, 1994)

FDA data resources