Altra Nova 200 Hemodialyzer
FDA 510(k) K970681 · Althin Medical AB an Affiliate of Baxter Intl
510(k) numberK970681
Submission
- Device name
- Altra Nova 200 Hemodialyzer
- Applicant
- Althin Medical AB an Affiliate of Baxter Intl
Miami Lakes, FL, US - Received
- February 24, 1997
- Decision date
- July 23, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MSF – Hemodialyzer, Re-Use, High Flux
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5860
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code MSF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K023615 | Gambro Polyflux 6 LR, 8 LR and 10 LRMSF · Traditional | Gambro Renal Products | 05/06/2003SE |
| K994390 | Gambro Polyflux 17R, Capillary Dialyzer/ FilterMSF · Traditional | Gambro Healthcare | 10/26/2000SE |
| K970679 | Altra Flux 200 HemodialyzerMSF · Traditional | Althin Medical AB an Affiliate of Baxter Intl | 07/23/1998SE |
| K970662 | Ca Cellulose Acetate Hollow Fiber Dialyzer (CA-170/CA-210)MSF · Traditional | Baxter Healthcare Corp | 03/11/1998SE |
| K970653 | Cahp High Performance Cellulose Diacetate (Capillary, Hollow Fiber)MSF · Traditional | Baxter Healthcare Corp | 03/11/1998SE |
| K970663 | CT Celluloser Triacetate Hollow Fiber Dialyzer (CT-110G/CT-190G)MSF · Traditional | Baxter Healthcare Corp | 01/11/1998SE |
| K970648 | Primus Hollow Fiber Dialyzer (Models 1000,1000S,1350,1350S,2000,2000S)MSF · Traditional | Renal Systems, Inc. | 01/05/1998SE |
More from Renal Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K990643 | PS 15 Polysulfone Hollow Fiber Membrane Hemodialyzer, Model 239-015KDI · Traditional | 12/07/1999SE |
| K970679 | Altra Flux 200 HemodialyzerMSF · Traditional | 07/23/1998SE |
| K970446 | Drake Willock System & Altra Touch 1000 Dialysis Delivery SystemKDI · Traditional | 06/02/1997SE |
| K964922 | Drake Willock System 1000 Dialysate Delivery System Altratouch 1000 Dialysate Delivery…KDI · Traditional | 05/21/1997SE |
| K955384 | Drake Willock System 1000 Dialysate Delivery System W/Single Needle Single Lumen OptionKDI · Traditional | 01/10/1997SE |
| K962309 | Alternate Encapsulating Resin System for Mca HemodialyzersFJI · Traditional | 12/27/1996SE |
| K954987 | Altratouch 1000 Hemodialysis Delivery SystemKDI · Traditional | 08/08/1996SE |
| K952983 | Altr Nova 110 HemodialyzerKDI · Traditional | 10/05/1995SE |
| K952982 | Altrex 110 HemodialyzerKDI · Traditional | 10/05/1995SE |
| K952978 | Altra Flux 110 HemodialyzerKDI · Traditional | 10/05/1995SE |
Questions and answers
When was Altra Nova 200 Hemodialyzer cleared by the FDA?
Altra Nova 200 Hemodialyzer (K970681) received a 510(k) decision of Substantially Equivalent on July 23, 1998, 514 days after the submission was received.
What is the product code of K970681?
The FDA product code is MSF – Hemodialyzer, Re-Use, High Flux, a Class II (moderate risk) device regulated under 21 CFR 876.5860.