Sepacell(R) R-200/500 Leukocyte Removal Recip Sets
FDA 510(k) K904223 · Baxter Healthcare Corp
510(k) numberK904223
Submission
- Device name
- Sepacell(R) R-200/500 Leukocyte Removal Recip Sets
- Applicant
- Baxter Healthcare Corp
Round Lake, IL, US - Received
- September 13, 1990
- Decision date
- October 26, 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
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| 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 |
| K904221 | Sepacell(R) PL-5A/10A Leukocyte Removal FiltersCAK · Traditional | Baxter Healthcare Corp | 10/26/1990SE |
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Questions and answers
When was Sepacell(R) R-200/500 Leukocyte Removal Recip Sets cleared by the FDA?
Sepacell(R) R-200/500 Leukocyte Removal Recip Sets (K904223) received a 510(k) decision of Substantially Equivalent on October 26, 1990, 43 days after the submission was received.
What is the product code of K904223?
The FDA product code is CAK – Microfilter, Blood Transfusion, a Class II (moderate risk) device regulated under 21 CFR 880.5440.