Biologic-Dt Machine, Model DT-1000 and Biologic-Dt Treatment Kit, Model DT-1000-TK

FDA 510(k) K984546 · Hemocleanse, Inc.

Substantially Equivalent

510(k) numberK984546

Submission

Device name
Biologic-Dt Machine, Model DT-1000 and Biologic-Dt Treatment Kit, Model DT-1000-TK
Applicant
Hemocleanse, Inc.
West Lafayette, IN, US
Received
December 22, 1998
Decision date
August 13, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FLD – Apparatus, Hemoperfusion, Sorbent
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5870
Specialty
Gastroenterology, Urology

Other 510(k)s with product code FLD

510(k)DeviceApplicantDecision
K133807Mars Monitor Itc US, Mars Treatment Kit Type 1116/1 - X-Mars US, Prismaflex Control UnitFLD · Traditional Gambro Renal Products, Inc.03/26/2014SE
K113313Molecular Adsorbent Recirculating(Mars)FLD · Traditional Gambro Renal Products, Inc.12/14/2012SE
K033262Molecular Adsorbent Recirculating System (Mars)FLD · Traditional Gambro Renal Products05/27/2005SE
K992196Biologic-Dt System (BIOLOGIC-DT-1000 with DT-1000-TK)FLD · Special Hemocleanse, Inc.09/10/1999SE
K971015Ahcs Hemoperfusion SystemFLD · Traditional American Health Care Systems, Inc.10/22/1997SE
K953751Biologic-Dt SystemFLD · Traditional Hemocleanse, Inc.02/15/1996SE
K885017Hemosorba CH-500, CH-350 and CH-180FLD · Traditional Asahi Medical Co., Ltd.03/17/1989SE
K873643Gambro Adsorba 150CFLD · Traditional Gambro, Inc.12/29/1987SE
K840532Hemoperfusion System TP-400FLD · Traditional Extracorporeal Medical Specialities, Inc.05/30/1984SE
K831029Hemoperfusion System TP-400FLD · Traditional Extracorporeal Medical Specialities, Inc.08/26/1983SE

More from Extracorporeal Medical Specialities, Inc.

510(k)DeviceDecision
K993330Thermochem-Ht SystemMLW · Traditional 12/30/1999SE
K992196Biologic-Dt System (BIOLOGIC-DT-1000 with DT-1000-TK)FLD · Special 09/10/1999SE
K953751Biologic-Dt SystemFLD · Traditional 02/15/1996SE
K923046Biologic DT-1000 MachineKNT · Traditional 09/30/1994SE

Questions and answers

When was Biologic-Dt Machine, Model DT-1000 and Biologic-Dt Treatment Kit, Model DT-1000-TK cleared by the FDA?

Biologic-Dt Machine, Model DT-1000 and Biologic-Dt Treatment Kit, Model DT-1000-TK (K984546) received a 510(k) decision of Substantially Equivalent on August 13, 1999, 234 days after the submission was received.

What is the product code of K984546?

The FDA product code is FLD – Apparatus, Hemoperfusion, Sorbent, a Class II (moderate risk) device regulated under 21 CFR 876.5870.