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FDA 510(k)

ViaValve Safety I.V. Catheter

K-Number: K160235 · 2016-06-30

ApplicantSmiths Medical Asd, Inc.
Decision Date2016-06-30
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ViaValve Safety I.V. Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical Asd, Inc.. It received FDA 510(k) clearance on 2016-06-30 under 510(k) number K160235. 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 ViaValve Safety I.V. Catheter?

ViaValve Safety I.V. Catheter is a medical device that received FDA 510(k) clearance on 2016-06-30. The listed applicant is Smiths Medical Asd, Inc.. The 510(k) number is K160235.

When did ViaValve Safety I.V. Catheter receive FDA 510(k) clearance?

ViaValve Safety I.V. Catheter received FDA 510(k) clearance on 2016-06-30, under 510(k) number K160235.

Who is the listed applicant for ViaValve Safety I.V. Catheter?

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

What is the FDA product code for ViaValve Safety I.V. Catheter?

The FDA product code for ViaValve Safety I.V. Catheter is FOZ.

Other records listing Smiths Medical Asd, Inc. as applicant

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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.

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.K252513Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)Poly Medicure Limited

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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