Sepacell R-500 and Sepacell R-500A
FDA 510(k) K873792 · Advocacy International, Ltd.
510(k) numberK873792
Submission
- Device name
- Sepacell R-500 and Sepacell R-500A
- Applicant
- Advocacy International, Ltd.
Washington, DC, US - Received
- September 17, 1987
- Decision date
- January 19, 1988
- 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 |
|---|---|---|
| K874027 | Lipase UV [Toyo]CHI · Traditional | 05/27/1988SE |
| K855251 | Modification Asahi New Pan-Series HemofiltersKDI · Traditional | 02/04/1986SE |
| K855212 | Asahi Am Series DialyzersFJI · Traditional | 01/21/1986SE |
| K854259 | Sepacell R-500 & Sepacell R-500ACAK · Traditional | 01/08/1986SE |
| K842103 | Toyo Jozo Uric Acid TestKNK · Traditional | 08/12/1984SE |
| K842104 | Toyo Jozo G-Gtp TestJPZ · Traditional | 08/10/1984SE |
| K830231 | Asahi Hollow Fiber Kidneys, Am-SeriesKOC · Traditional | 03/17/1983SE |
| K830183 | Asahi Hollow Fiber Kidneys NR SeriesKOC · Traditional | 03/17/1983SE |
| K823733 | Eiken Kizai Artificial Kidney Blood CirKOC · Traditional | 01/14/1983SE |
| K813037 | Flowguard Catheters & CannalaeDWF · Traditional | 12/14/1981SE |
Questions and answers
When was Sepacell R-500 and Sepacell R-500A cleared by the FDA?
Sepacell R-500 and Sepacell R-500A (K873792) received a 510(k) decision of Substantially Equivalent on January 19, 1988, 124 days after the submission was received.
What is the product code of K873792?
The FDA product code is CAK – Microfilter, Blood Transfusion, a Class II (moderate risk) device regulated under 21 CFR 880.5440.