510(k) K073339
- Device
- BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR
- Applicant
- FENWAL, INC.
- 510(k) number
- K073339
- Product code
- BRZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-03-03
- Date received
- 2007-11-28
- Regulation
- 880.5440
- Classification name
- Set, 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
- TAMMY DAVIS
- Address
- Three Corporate Dr. Lake Zurich IL US 60047 60047
FDA Registration Numbers#
- 9612051
- 3013557562
- 1416980
- 3030447506
- 3033536319
- 3003704957
- 1061124
- 3013517171
- 3002907620
- 1319639
- 3010432890
- 9616066
- 2029275
- 3010934635
- 1018470
- 3011237770
- 3006788678
- 8020785
- 1066733
- 3002808468
- 3004548776
- 2032098
- 1422078
- 9612052
- 3012410077
- 8040700
- 3015276780
- 1423507
Source Documents#
Other 510(k) Records For Product Code BRZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K220558 | Blood Administration Sets | Baxter Healthcare Corporation | 2022-11-17 |
| K210335 | Blood Administration Set | Baxter Healthcare Corporation | 2021-06-10 |
| K132905 | 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER | Arteriocyte Medical Systems, Inc. | 2013-10-04 |
| K083349 | BLOOD TRANSFUSION SET | Shan Dong Wei Gao Group Medical Polymer Products | 2009-04-10 |
| K041496 | PENTATRASFU BLOOD TRANSFUSION SETS | Pentaferte S.P.A | 2005-06-30 |
| K050805 | 30 ML OR 60 ML PEDI-SYRINGE FILTER | Blood Products Specialties, LLC | 2005-06-20 |
| K050115 | BLOOD HAND PUMP ADMINISTRATION SET | Cardinal Health, Alaris Products | 2005-04-01 |
| K023039 | BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015 | Tuta Healthcare Pty Limited | 2002-11-07 |
| K000685 | CHARTER MEDICAL NEONATAL SYRINGE SET | Charter Medical, Ltd. | 2000-08-15 |
| K993120 | MODIFIED BLOOD RECIPIENT SET | Baxter Healthcare Corp | 1999-11-17 |
| K972843 | PROTOS BLOOD TRANSFUSION SET | Globe Ent., Inc. | 1997-12-16 |
| K940074 | Y-TYPE BLOOD ADMINISTRATION SET | Puritas Health Care, Inc. | 1994-04-21 |
| K940055 | MULTISET | Puritas Health Care, Inc. | 1994-04-15 |
| K921595 | Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2 | Haemotronic, Inc. | 1992-12-24 |
| K920788 | BLOOD ADMINISTRATION SET | Douglas Medical Products Corp. | 1992-06-04 |
Legacy Summary#
summary
FDA Review#
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