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FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72

FDA 510(k) clearance K982822 · decided 1998-09-30

Clearance details

K-number
K982822
Device name
FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72
Applicant
Baxter Healthcare Corp
Decision
Substantially Equivalent
Date received
1998-08-11
Decision date
1998-09-30
Days to decision
50 days
Clearance type
Traditional
Product code
CAK
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Round Lake, IL, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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NEOCARE 20 MICRON BLOOD FILTER (K000719)Whatman, Inc.2000-05-30
CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER) (K990310)Charter Medical, Ltd.1999-08-30
FENWAL 40 MICRON TRANSFUSION FILTER (K972159)Baxter Healthcare Corp1997-07-23
ALPHA MICRON 20/40 MICROAGGREGATE FILTER (K970225)Alpha Therapeutic Corp.1997-02-14
PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST) (K960993)Pall Biomedical Products Co.1996-04-22
ALPHA MICRON 20 MICROAGGREGATE FILTER (K955515)Alpha Therapeutic Corp.1996-02-12
SEPACELL(R) PL-5A/10A LEUKOCYTE REMOVAL FILTERS (K904221)Baxter Healthcare Corp1990-10-26
SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETS (K904223)Baxter Healthcare Corp1990-10-26
MODIFIED SEPACELL R-SERIES BLOOD FILTERS (K901887)Asahi Medical Co., Ltd.1990-08-08
SOLCOSEPT(TM) BLOOD TRANSFUSION FILTER (K896203)Solco Basle, Inc.1990-02-01

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma (P990009/S077)Baxter Healthcare Corp2025-11-13
FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT (P990009/S076)Baxter Healthcare Corp2025-06-30
Floseal Hemostatic Matrix (P990009/S075)Baxter Healthcare Corp2025-01-30
Adept Adhesion Reduction Solution (P050011/S009)Baxter Healthcare Corp2024-08-23
Floseal Hemostatic Matrix, Floseal with Recothrom, Floseal Hemostatic Matrix, Floseal Fast Prep (P990009/S074)Baxter Healthcare Corp2024-08-15
Floseal Hemostatic Matrix (P990009/S073)Baxter Healthcare Corp2024-01-10
Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RTS (P990009/S072)Baxter Healthcare Corp2023-12-12
Floseal Hemostatic Matrix, RT5 (P990009/S070)Baxter Healthcare Corp2023-02-02