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FDA 510(k)

BLOOD COLLECTION SET, STERILE, DISPOS.

K-Number: K841187 · 1984-06-22

ApplicantMarbex, Inc.
Decision Date1984-06-22
Product CodeBRZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BLOOD COLLECTION SET, STERILE, DISPOS. is the device name listed in this FDA 510(k) record. The listed applicant is Marbex, Inc.. It received FDA 510(k) clearance on 1984-06-22 under 510(k) number K841187. 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 COLLECTION SET, STERILE, DISPOS.?

BLOOD COLLECTION SET, STERILE, DISPOS. is a medical device that received FDA 510(k) clearance on 1984-06-22. The listed applicant is Marbex, Inc.. The 510(k) number is K841187.

When did BLOOD COLLECTION SET, STERILE, DISPOS. receive FDA 510(k) clearance?

BLOOD COLLECTION SET, STERILE, DISPOS. received FDA 510(k) clearance on 1984-06-22, under 510(k) number K841187.

Who is the listed applicant for BLOOD COLLECTION SET, STERILE, DISPOS.?

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

What is the FDA product code for BLOOD COLLECTION SET, STERILE, DISPOS.?

The FDA product code for BLOOD COLLECTION SET, STERILE, DISPOS. is BRZ.

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Other records listing Marbex, 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.

K841185PLASTIC, STERILE TUBING CLOSED SETK841186INFUSION SET SCALP VEINK834368SURGICAL DISPOSABLE STERILE & NONSTERIL

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 ProductsK073339BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTORFenwal, Inc.K041496PENTATRASFU BLOOD TRANSFUSION SETSPentaferte S.P.A

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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