Modified Sepacell R-500 and R-500A Blood Filters
FDA 510(k) K896976 · Asahi Medical Co., Ltd.
510(k) numberK896976
Submission
- Device name
- Modified Sepacell R-500 and R-500A Blood Filters
- Applicant
- Asahi Medical Co., Ltd.
Washington, DC, US - Received
- December 13, 1989
- Decision date
- January 24, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CAK – Microfilter, Blood Transfusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
Other 510(k)s with product code CAK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K061103 | Haemonetics 40U RBC Filter BagCAK · Traditional | Haemonetics Corp. | 05/17/2006SE |
| K022477 | Summit Medical Ltd Transfusion Filter, Model LF400 & Summit Medical Ltd Transfusion…CAK · Traditional | Summit Medical , Ltd. | 10/25/2002SE |
| K000719 | Neocare 20 Micron Blood FilterCAK · Traditional | Whatman, Inc. | 05/30/2000SE |
| K990310 | Charter Medical, Ltd MP 450 (40 Micron Filter)CAK · Traditional | Charter Medical, Ltd. | 08/30/1999SE |
| K982822 | Fenwal 20 Micron Pediatric Transfusion Filter Model 4C7701, Fenwal 20 Micron Pediatric…CAK · Traditional | Baxter Healthcare Corp | 09/30/1998SE |
| K972159 | Fenwal 40 Micron Transfusion FilterCAK · Traditional | Baxter Healthcare Corp | 07/23/1997SE |
| K970225 | Alpha Micron 20/40 Microaggregate FilterCAK · Traditional | Alpha Therapeutic Corp. | 02/14/1997SE |
| K960993 | Pall SQ40S Blood Filter (SQ40S/SQ40ST)CAK · Traditional | Pall Biomedical Products Co. | 04/22/1996SE |
| K955515 | Alpha Micron 20 Microaggregate FilterCAK · Traditional | Alpha Therapeutic Corp. | 02/12/1996SE |
| K904223 | Sepacell(R) R-200/500 Leukocyte Removal Recip SetsCAK · Traditional | Baxter Healthcare Corp | 10/26/1990SE |
More from Baxter Healthcare Corp
| 510(k) | Device | Decision |
|---|---|---|
| K041726 | High Flux Hemodialysis Membrane Dialyzer or High Flux Hollow Fiber Dialyzer, Models…KDI · Special | 07/23/2004SE |
| K013418 | Am-Bio Extended Range Series Dialyzer, Models Wet and DryKDI · Traditional | 07/09/2002SE |
| K001250 | Aps Series Dialyzers (Wet Models), Aps Series Dialysis (Dry Models)KDI · Traditional | 08/16/2000SE |
| K991512 | Asahi Am-R-Series Dialyzers (Modified), Model Am-Nr-XFJI · Traditional | 07/29/1999SE |
| K983720 | Asahi Am-Bio Series Dialyzers (Wet Models)& (Dry Models), Models AM-BIO-50,AM-BIO-65…MSE · Traditional | 05/17/1999SE |
| K970650 | Asahi Am-R Series DialyzersMSE · Traditional | 09/30/1997SE |
| K914020 | Modified Asahi Pan-Series HemofiltersKDI · Traditional | 03/20/1992SE |
| K901887 | Modified Sepacell R-Series Blood FiltersCAK · Traditional | 08/08/1990SE |
| K896664 | Modified Sepacell Pl-Series Leukocyte Removal FiltCAK · Traditional | 01/24/1990SE |
| K892375 | Modified Am-Series DialyzersFJI · Traditional | 05/18/1989SE |
Questions and answers
When was Modified Sepacell R-500 and R-500A Blood Filters cleared by the FDA?
Modified Sepacell R-500 and R-500A Blood Filters (K896976) received a 510(k) decision of Substantially Equivalent on January 24, 1990, 42 days after the submission was received.
What is the product code of K896976?
The FDA product code is CAK – Microfilter, Blood Transfusion, a Class II (moderate risk) device regulated under 21 CFR 880.5440.