Atlas FDA

PENTATRASFU BLOOD TRANSFUSION SETS

FDA 510(k) clearance K041496 · decided 2005-06-30

Clearance details

K-number
K041496
Device name
PENTATRASFU BLOOD TRANSFUSION SETS
Applicant
Pentaferte S.P.A
Decision
Substantially Equivalent
Date received
2004-06-04
Decision date
2005-06-30
Days to decision
391 days
Clearance type
Abbreviated
Product code
BRZ
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Parkland, FL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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

RecordFirmDate
Blood Administration Sets (K220558)Baxter Healthcare Corporation2022-11-17
Blood Administration Set (K210335)Baxter Healthcare Corporation2021-06-10
200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER (K132905)Arteriocyte Medical Systems, Inc.2013-10-04
BLOOD TRANSFUSION SET (K083349)Shan Dong Wei Gao Group Medical Polymer Products2009-04-10
BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR (K073339)Fenwal, Inc.2008-03-03
30 ML OR 60 ML PEDI-SYRINGE FILTER (K050805)Blood Products Specialties, LLC2005-06-20
BLOOD HAND PUMP ADMINISTRATION SET (K050115)Cardinal Health, Alaris Products2005-04-01
BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015 (K023039)Tuta Healthcare Pty Limited2002-11-07
CHARTER MEDICAL NEONATAL SYRINGE SET (K000685)Charter Medical, Ltd.2000-08-15
MODIFIED BLOOD RECIPIENT SET (K993120)Baxter Healthcare Corp1999-11-17
PROTOS BLOOD TRANSFUSION SET (K972843)Globe Ent., Inc.1997-12-16
Y-TYPE BLOOD ADMINISTRATION SET (K940074)Puritas Health Care, Inc.1994-04-21

Recalls involving this device

No recalls on record reference this clearance.