Apparatus, Hemoperfusion, Sorbent
FDA product code FLD · Class II (moderate risk) · 21 CFR 876.5870 · Gastroenterology, Urology
11510(k) clearances
0PMA approvals
7recalls
Manufacturers
510(k) clearances
| 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 |
| K992196 | Biologic-Dt System (BIOLOGIC-DT-1000 with DT-1000-TK)FLD · Special | Hemocleanse, Inc. | 09/10/1999SE |
| 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 |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0411-2018 Class II | MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541Baxter has received customer complaints regarding leakage in the albumin circuit. The leakage was caused by… | Baxter Healthcare Corporation | 12/21/2017Terminated |
| Z-2207-2014 Class II | X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting… | Gambro Renal Products, Incorporated | 07/18/2014Terminated |
| Z-2206-2014 Class II | PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment…Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting… | Gambro Renal Products, Incorporated | 07/18/2014Terminated |
| Z-0553-2007 | Clark Biocompatible Hemoperfusion Cartridge, sorbent: Heparinized polymer over…Lack of sterility assurance based on lack of sterility validation for labeled sterilization directions | Clark Research and Development Inc | 01/19/2007Terminated |
| Z-0552-2007 | Clark Biocompatible Hemoperfusion Cartridge, Sorbent: Heparinized polymer over…Lack of sterility assurance based on lack of sterility validation for labeled sterilization directions | Clark Research and Development Inc | 01/19/2007Terminated |
| Z-0551-2007 | Clark Biocompatible Hemoperfusion Cartridge, Sorbent: Heparinized polymer over…Lack of sterility assurance based on lack of sterility validation for labeled sterilization directions | Clark Research and Development Inc | 01/19/2007Terminated |
| Z-0550-2007 | Clark Biocompatible Hemoperfusion Cartridge, Sorbent: Heparinized polymer over…Lack of sterility assurance based on lack of sterility validation for labeled sterilization directions | Clark Research and Development Inc | 01/19/2007Terminated |