Product code CAK
- Device name
- Microfilter, Blood Transfusion
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5440
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K061103 | HAEMONETICS 40U RBC FILTER BAG | Haemonetics Corp. | 2006-05-17 |
| K022477 | SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET | Summit Medical , Ltd. | 2002-10-25 |
| K000719 | NEOCARE 20 MICRON BLOOD FILTER | Whatman, Inc. | 2000-05-30 |
| K990310 | CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER) | Charter Medical, Ltd. | 1999-08-30 |
| K982822 | FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72 | Baxter Healthcare Corp | 1998-09-30 |
| K972159 | FENWAL 40 MICRON TRANSFUSION FILTER | Baxter Healthcare Corp | 1997-07-23 |
| K970225 | ALPHA MICRON 20/40 MICROAGGREGATE FILTER | Alpha Therapeutic Corp. | 1997-02-14 |
| K960993 | PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST) | Pall Biomedical Products Co. | 1996-04-22 |
| K955515 | ALPHA MICRON 20 MICROAGGREGATE FILTER | Alpha Therapeutic Corp. | 1996-02-12 |
| K904223 | SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETS | Baxter Healthcare Corp | 1990-10-26 |
| K904221 | SEPACELL(R) PL-5A/10A LEUKOCYTE REMOVAL FILTERS | Baxter Healthcare Corp | 1990-10-26 |
| K901887 | MODIFIED SEPACELL R-SERIES BLOOD FILTERS | Asahi Medical Co., Ltd. | 1990-08-08 |
| K896203 | SOLCOSEPT(TM) BLOOD TRANSFUSION FILTER | Solco Basle, Inc. | 1990-02-01 |
| K896664 | MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT | Asahi Medical Co., Ltd. | 1990-01-24 |
| K896976 | MODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERS | Asahi Medical Co., Ltd. | 1990-01-24 |
| K890844 | MICROSEPT 60/20 | Arbor Technologies, Inc. | 1989-06-07 |
| K873792 | SEPACELL R-500 AND SEPACELL R-500A | Advocacy International, Ltd. | 1988-01-19 |
| K873666 | PALL LEUKOCYTE REMOVAL FILTER, BLOOD | Pall Biomedical Products Co. | 1988-01-06 |
| K873667 | PALL LEUKOCYTE REMOVAL FILTER, PLATELETS | Pall Biomedical Products Co. | 1988-01-06 |
| K873873 | RESUBMITTED MICRON TRANSFUSION FILTER | Travenol Laboratories, S.A. | 1987-10-22 |
| K864636 | ERYPUR B | Organon Teknika Corp. | 1987-01-14 |
| K855064 | SWANK BLOOD TRANSFUSION MICRO-FILTER W/STRAIGHT SE | Cobe Laboratories, Inc. | 1986-03-12 |
| K854259 | SEPACELL R-500 & SEPACELL R-500A | Advocacy International, Ltd. | 1986-01-08 |
| K851370 | INTERFACE TRANSFUSION BLOOD FILTER #35 | Medical, Inc. | 1985-06-27 |
| K830057 | 20 MICRON HIGH CAPACITY TRANS/FILTER | Travenol Laboratories, S.A. | 1983-01-26 |
| K830014 | HEMA - NV TRANS. BLOOD FILTER 100/800 | Abbott Laboratories | 1983-01-17 |
| K823261 | INTERFACE TRANSFUSION BLOOD FILTER #30 | Medical, Inc. | 1983-01-07 |
| K812874 | PEDIATRIC MICROAGGREGATE BLOOD FILTER | Abbott Laboratories | 1981-11-02 |
| K812697 | HEMA 20 MICRON TRANSFUSION BLOOD FILTER | Abbott Laboratories | 1981-10-08 |
| K811985 | ULTIPOR SQ40S BLOOD TRANSFUSION FILTER | Pall Biomedical Products Co. | 1981-07-28 |
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|---|---|---|---|
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| 10810197810170 | GVS | Gvs Tm, Inc. | 2026-01-19 |
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