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FDA 510(k)

THE AVITRO LLC, 10 AND 100 USO UNITS/ML HEPARIN SODIUM VAFD

K-Number: K001795 · 2000-10-19

ApplicantAvitro, LLC
Decision Date2000-10-19
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

THE AVITRO LLC, 10 AND 100 USO UNITS/ML HEPARIN SODIUM VAFD is the device name listed in this FDA 510(k) record. The listed applicant is Avitro, LLC. It received FDA 510(k) clearance on 2000-10-19 under 510(k) number K001795. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE AVITRO LLC, 10 AND 100 USO UNITS/ML HEPARIN SODIUM VAFD?

THE AVITRO LLC, 10 AND 100 USO UNITS/ML HEPARIN SODIUM VAFD is a medical device that received FDA 510(k) clearance on 2000-10-19. The listed applicant is Avitro, LLC. The 510(k) number is K001795.

When did THE AVITRO LLC, 10 AND 100 USO UNITS/ML HEPARIN SODIUM VAFD receive FDA 510(k) clearance?

THE AVITRO LLC, 10 AND 100 USO UNITS/ML HEPARIN SODIUM VAFD received FDA 510(k) clearance on 2000-10-19, under 510(k) number K001795.

Who is the listed applicant for THE AVITRO LLC, 10 AND 100 USO UNITS/ML HEPARIN SODIUM VAFD?

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

What is the FDA product code for THE AVITRO LLC, 10 AND 100 USO UNITS/ML HEPARIN SODIUM VAFD?

The FDA product code for THE AVITRO LLC, 10 AND 100 USO UNITS/ML HEPARIN SODIUM VAFD is FOZ.

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Other records listing Avitro, LLC 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.

K0006320.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE

Related Devices (Code: FOZ)

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.

K260432Ruby Intravascular CatheterVenocare, Inc.K260165Unimpregnated Central Venous CatheterSpectrum VascularK261041ClearSafe Closed SystemMedSource Labs, LLCK260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLCK253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.

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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