BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR

FDA 510(k) clearance K073339 · decided 2008-03-03

Clearance details

K-number: K073339
Device name: BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR
Applicant: Fenwal, Inc.
Decision: Substantially Equivalent
Date received: 2007-11-28
Decision date: 2008-03-03
Days to decision: 96 days
Clearance type: Traditional
Product code: BRZ
Device class: 2
Regulation number: 880.5440
Medical specialty: General Hospital
Advisory committee: General Hospital
Location: Lake Zurich, 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.

Record	Firm	Date
Blood Administration Sets (K220558)	Baxter Healthcare Corporation	2022-11-17
Blood Administration Set (K210335)	Baxter Healthcare Corporation	2021-06-10
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 Products	2009-04-10
PENTATRASFU BLOOD TRANSFUSION SETS (K041496)	Pentaferte S.P.A	2005-06-30
30 ML OR 60 ML PEDI-SYRINGE FILTER (K050805)	Blood Products Specialties, LLC	2005-06-20
BLOOD HAND PUMP ADMINISTRATION SET (K050115)	Cardinal Health, Alaris Products	2005-04-01
BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015 (K023039)	Tuta Healthcare Pty Limited	2002-11-07
CHARTER MEDICAL NEONATAL SYRINGE SET (K000685)	Charter Medical, Ltd.	2000-08-15
MODIFIED BLOOD RECIPIENT SET (K993120)	Baxter Healthcare Corp	1999-11-17
PROTOS BLOOD TRANSFUSION SET (K972843)	Globe Ent., Inc.	1997-12-16
Y-TYPE BLOOD ADMINISTRATION SET (K940074)	Puritas Health Care, Inc.	1994-04-21

No recalls on record reference this clearance.