Renatron II Dialyzer Reprocessing System RS 8330
FDA 510(k) K904210 · Minntech Corp.
510(k) numberK904210
Submission
- Device name
- Renatron II Dialyzer Reprocessing System RS 8330
- Applicant
- Minntech Corp.
Minneapolis, MN, US - Received
- September 12, 1990
- Decision date
- November 27, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LIF – Dialyzer Reprocessing System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code LIF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K091360 | Clearflux Dialyzer Reprocessing SystemLIF · Traditional | Novaflux Technologies | 11/03/2010SE |
| K043126 | Assist Header CleanerLIF · Traditional | Alcavis International, Inc. | 02/03/2005SE |
| K040660 | Sterichek Glutaraldehyde Reagent StripsLIF · Traditional | Hach Company | 11/15/2004SE |
| K033505 | Renaclean SH Dialyzer Cleaning SystemLIF · Traditional | Minntech Corp. | 04/27/2004SE |
| K024076 | Maky 21.1 Dialyzer Reprocessing SystemLIF · Traditional | Hdc Maquinolas, LLC | 09/26/2003SE |
| K013713 | Arm Automatic Reprocessing MachineLIF · Traditional | Alcavis International Incorporated | 07/15/2002SE |
| K992016 | Amukin DLIF · Traditional | Amuchina Intl., Inc. | 01/10/2000SE |
| K991851 | Renaclear Dialyzer Cleaning SystemLIF · Traditional | Minntech Corp. | 08/30/1999SE |
| K974426 | Potency Test Strips, Indicator Test StripsLIF · Traditional | Reprocessing Products Corp | 02/10/1999SE |
| K974798 | Sterichek(Tm) Residual Peroxide Reagent StrpsLIF · Traditional | Environmental Test Systems, Inc. | 03/20/1998SE |
More from Environmental Test Systems, Inc.
| 510(k) | Device | Decision |
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| K120306 | Rapicide OPA-28MED · Traditional | 09/27/2012SE |
| K092387 | Medivators DSD Edge Endoscope Reprocessing SystemFEB · Traditional | 04/05/2010SE |
| K071298 | HF Junior HemofilterKDI · Traditional | 08/08/2007SE |
| K050952 | HPH Junior High Performance HemoconcentratorKDI · Traditional | 01/31/2006SE |
| K033505 | Renaclean SH Dialyzer Cleaning SystemLIF · Traditional | 04/27/2004SE |
| K014016 | Enguard CHC Dual Reservoir Cardioplegia Heater/CoolerDWC · Traditional | 02/01/2002SE |
| K991137 | Enguard PHX Cardioplegia Heat ExchangerDTR · Traditional | 06/08/2000SE |
| K000028 | Renaflo II HF 2000 HemofilterKDI · Traditional | 04/04/2000SE |
| K991851 | Renaclear Dialyzer Cleaning SystemLIF · Traditional | 08/30/1999SE |
| K983126 | Fiberflo Hollow Fiber Capsule Water FiltersFIP · Traditional | 03/08/1999SE |
Questions and answers
When was Renatron II Dialyzer Reprocessing System RS 8330 cleared by the FDA?
Renatron II Dialyzer Reprocessing System RS 8330 (K904210) received a 510(k) decision of Substantially Equivalent on November 27, 1990, 76 days after the submission was received.
What is the product code of K904210?
The FDA product code is LIF – Dialyzer Reprocessing System, a Class II (moderate risk) device regulated under 21 CFR 876.5820.