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FDA 510(k)

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

K-Number: K073339 · 2008-03-03

ApplicantFenwal, Inc.
Decision Date2008-03-03
Product CodeBRZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Fenwal, Inc.. It received FDA 510(k) clearance on 2008-03-03 under 510(k) number K073339. The device is classified under product code BRZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR?

BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR is a medical device that received FDA 510(k) clearance on 2008-03-03. The listed applicant is Fenwal, Inc.. The 510(k) number is K073339.

When did BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR receive FDA 510(k) clearance?

BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR received FDA 510(k) clearance on 2008-03-03, under 510(k) number K073339.

Who is the listed applicant for BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR?

The FDA 510(k) record lists Fenwal, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR?

The FDA product code for BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR is BRZ.

Related Clinical Trials

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Other records listing Fenwal, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K111702AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE

Related Devices (Code: BRZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220558Blood Administration SetsBaxter Healthcare CorporationK210335Blood Administration SetBaxter Healthcare CorporationK132905200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTERArteriocyte Medical Systems, Inc.K083349BLOOD TRANSFUSION SETShan Dong Wei Gao Group Medical Polymer ProductsK041496PENTATRASFU BLOOD TRANSFUSION SETSPentaferte S.P.AK05080530 ML OR 60 ML PEDI-SYRINGE FILTERBlood Products Specialties, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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