BLOOD TRANSFUSION SET— 510(k) K083349

Name: FDA 510(k) clearance K083349
Creator: U.S. Food and Drug Administration
Published: 2009-04-10

Substantially Equivalent

Shan Dong Wei Gao Group Medical Polymer Products

FDA 510(k) clearance K083349 for BLOOD TRANSFUSION SET, Substantially Equivalent on 2009-04-10. Applicant: Shan Dong Wei Gao Group Medical Polymer Products. Device class: 2.

Clearance details

Applicant: Shan Dong Wei Gao Group Medical Polymer Products
Product code: Code BRZ
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 2008-11-13
Decision date: 2009-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shan Nan Er Rd., Shanghai, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code BRZ

view all

K220558 — Blood Administration Sets2022-11-17
K210335 — Blood Administration Set2021-06-10
K132905 — 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER2013-10-04
K073339 — BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR2008-03-03
K041496 — PENTATRASFU BLOOD TRANSFUSION SETS2005-06-30

More clearances from Shan Dong Wei Gao Group Medical Polymer Products

view all

K090459 — DISPOSABLE TPE INFUSION SET2009-10-13
K090012 — DISPOSABLE INFUSION SET2009-06-11

Adverse events under product code BRZ

product code BRZ

Malfunction: 458
Total: 458

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.