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FDA 510(k)

0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE

K-Number: K000632 · 2000-10-19

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

Device Summary

0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE 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 K000632. 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 0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE?

0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE 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 K000632.

When did 0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE receive FDA 510(k) clearance?

0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE received FDA 510(k) clearance on 2000-10-19, under 510(k) number K000632.

Who is the listed applicant for 0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE?

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 0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE?

The FDA product code for 0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE is FOZ.

Related Clinical Trials

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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.

K001795THE AVITRO LLC, 10 AND 100 USO UNITS/ML HEPARIN SODIUM VAFD

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

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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