Biologic-Dt System (BIOLOGIC-DT-1000 with DT-1000-TK)
FDA 510(k) K992196 · Hemocleanse, Inc.
510(k) numberK992196
Submission
- Device name
- Biologic-Dt System (BIOLOGIC-DT-1000 with DT-1000-TK)
- Applicant
- Hemocleanse, Inc.
West Lafayette, IN, US - Received
- June 30, 1999
- Decision date
- September 10, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
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) | Device | Applicant | Decision |
|---|---|---|---|
| K133807 | Mars Monitor Itc US, Mars Treatment Kit Type 1116/1 - X-Mars US, Prismaflex Control UnitFLD · Traditional | Gambro Renal Products, Inc. | 03/26/2014SE |
| K113313 | Molecular Adsorbent Recirculating(Mars)FLD · Traditional | Gambro Renal Products, Inc. | 12/14/2012SE |
| K033262 | Molecular Adsorbent Recirculating System (Mars)FLD · Traditional | Gambro Renal Products | 05/27/2005SE |
| K984546 | Biologic-Dt Machine, Model DT-1000 and Biologic-Dt Treatment Kit, Model DT-1000-TKFLD · Traditional | Hemocleanse, Inc. | 08/13/1999SE |
| K971015 | Ahcs Hemoperfusion SystemFLD · Traditional | American Health Care Systems, Inc. | 10/22/1997SE |
| K953751 | Biologic-Dt SystemFLD · Traditional | Hemocleanse, Inc. | 02/15/1996SE |
| K885017 | Hemosorba CH-500, CH-350 and CH-180FLD · Traditional | Asahi Medical Co., Ltd. | 03/17/1989SE |
| K873643 | Gambro Adsorba 150CFLD · Traditional | Gambro, Inc. | 12/29/1987SE |
| K840532 | Hemoperfusion System TP-400FLD · Traditional | Extracorporeal Medical Specialities, Inc. | 05/30/1984SE |
| K831029 | Hemoperfusion System TP-400FLD · Traditional | Extracorporeal Medical Specialities, Inc. | 08/26/1983SE |
More from Extracorporeal Medical Specialities, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K993330 | Thermochem-Ht SystemMLW · Traditional | 12/30/1999SE |
| K984546 | Biologic-Dt Machine, Model DT-1000 and Biologic-Dt Treatment Kit, Model DT-1000-TKFLD · Traditional | 08/13/1999SE |
| K953751 | Biologic-Dt SystemFLD · Traditional | 02/15/1996SE |
| K923046 | Biologic DT-1000 MachineKNT · Traditional | 09/30/1994SE |
Questions and answers
When was Biologic-Dt System (BIOLOGIC-DT-1000 with DT-1000-TK) cleared by the FDA?
Biologic-Dt System (BIOLOGIC-DT-1000 with DT-1000-TK) (K992196) received a 510(k) decision of Substantially Equivalent on September 10, 1999, 72 days after the submission was received.
What is the product code of K992196?
The FDA product code is FLD – Apparatus, Hemoperfusion, Sorbent, a Class II (moderate risk) device regulated under 21 CFR 876.5870.