510(k) K982822
- Device
- FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72
- Applicant
- BAXTER HEALTHCARE CORP.
- 510(k) number
- K982822
- Product code
- CAK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-09-30
- Date received
- 1998-08-11
- Regulation
- 880.5440
- Classification name
- Microfilter, Blood Transfusion
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARY ELLEN SNYDER
- Address
- Rt. 120 & Wilson Rd. Round Lake IL US 60073 60073
FDA Registration Numbers#
- 3003775072
- 9612051
- 3014936217
- 3004548776
- 3017174574
- 9710488
- 2650143
- 1066733
- 3037389071
- 2029275
- 3004404323
- 1526534
- 1058584
- 3016844398
Source Documents#
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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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