510(k) BK080060
- Device
- Blood Transfusion Microfilters
- Applicant
- MacoProductions S.A.S.
- 510(k) number
- BK080060
- Product code
- CAK
- Decision
- Substantially Equivalent (SE)
- Decision date
- 2009-01-14
- Date received
- 2008-10-31
- Regulation
- 880.5440
- Classification name
- Microfilter, Blood Transfusion
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Clearance type
- 510(k) Traditio
- Third party reviewed
- No
Other 510(k) Records For Product Code CAK #
| 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 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases