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FDA 510(k)

200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER

K-Number: K132905 · 2013-10-04

ApplicantArteriocyte Medical Systems, Inc.
Decision Date2013-10-04
Product CodeBRZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER is the device name listed in this FDA 510(k) record. The listed applicant is Arteriocyte Medical Systems, Inc.. It received FDA 510(k) clearance on 2013-10-04 under 510(k) number K132905. 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 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER?

200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER is a medical device that received FDA 510(k) clearance on 2013-10-04. The listed applicant is Arteriocyte Medical Systems, Inc.. The 510(k) number is K132905.

When did 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER receive FDA 510(k) clearance?

200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER received FDA 510(k) clearance on 2013-10-04, under 510(k) number K132905.

Who is the listed applicant for 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER?

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

What is the FDA product code for 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER?

The FDA product code for 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER is BRZ.

Related Clinical Trials

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.

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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 CorporationK083349BLOOD TRANSFUSION SETShan Dong Wei Gao Group Medical Polymer ProductsK073339BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTORFenwal, Inc.K041496PENTATRASFU BLOOD TRANSFUSION SETSPentaferte S.P.AK05080530 ML OR 60 ML PEDI-SYRINGE FILTERBlood Products Specialties, LLC

Official Source

View on FDA Database →

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

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