Alternate Encapsulating Resin System for Mca Hemodialyzers
FDA 510(k) K962309 · Althin Medical AB an Affiliate of Baxter Intl
510(k) numberK962309
Submission
- Device name
- Alternate Encapsulating Resin System for Mca Hemodialyzers
- Applicant
- Althin Medical AB an Affiliate of Baxter Intl
Miami Lakes, FL, US - Received
- June 17, 1996
- Decision date
- December 27, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FJI – Dialyzer, Capillary, Hollow Fiber
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code FJI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K190459 | Hemoflow F3 and F4 DialyzersFJI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 08/23/2019SE |
| K122952 | Nipro Pureflux-L HemodialyzerFJI · Traditional | Nipro Medical Corporation | 12/04/2013SE |
| K043342 | Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple Use, Models 14L…FJI · Traditional | Gambro Renal Products | 05/27/2005SE |
| K010366 | Disposable Storage CapFJI · Abbreviated | Molded Products, Inc. | 11/28/2001SE |
| K011148 | Ultraconcentrator SystemFJI · Special | Interpore Cross Intl. | 06/13/2001SE |
| K002761 | Fresnius Hemoflow F7NR, F50NR, F70NR HemodialyzersFJI · Traditional | Fresenius Medical Care North America | 12/04/2000SE |
| K991908 | Idemsa Hemophan Hollow Fiber DialyzersFJI · Traditional | Idemsa | 04/17/2000SE |
| K992594 | A-15 HemodialyzerFJI · Traditional | Althin Medical AB | 09/24/1999SE |
| K992565 | A-18 HemodialyzerFJI · Traditional | Althin Medical AB | 09/23/1999SE |
| K991512 | Asahi Am-R-Series Dialyzers (Modified), Model Am-Nr-XFJI · Traditional | Asahi Medical Co., Ltd. | 07/29/1999SE |
More from Asahi Medical Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K990643 | PS 15 Polysulfone Hollow Fiber Membrane Hemodialyzer, Model 239-015KDI · Traditional | 12/07/1999SE |
| K970681 | Altra Nova 200 HemodialyzerMSF · Traditional | 07/23/1998SE |
| 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 |
| 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 Alternate Encapsulating Resin System for Mca Hemodialyzers cleared by the FDA?
Alternate Encapsulating Resin System for Mca Hemodialyzers (K962309) received a 510(k) decision of Substantially Equivalent on December 27, 1996, 193 days after the submission was received.
What is the product code of K962309?
The FDA product code is FJI – Dialyzer, Capillary, Hollow Fiber, a Class II (moderate risk) device regulated under 21 CFR 876.5820.