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FDA 510(k)

Ruby Intravascular Catheter

K-Number: K243105 · 2025-05-16

ApplicantVenocare, Inc.
Decision Date2025-05-16
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Ruby Intravascular Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Venocare, Inc.. It received FDA 510(k) clearance on 2025-05-16 under 510(k) number K243105. 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 Ruby Intravascular Catheter?

Ruby Intravascular Catheter is a medical device that received FDA 510(k) clearance on 2025-05-16. The listed applicant is Venocare, Inc.. The 510(k) number is K243105.

When did Ruby Intravascular Catheter receive FDA 510(k) clearance?

Ruby Intravascular Catheter received FDA 510(k) clearance on 2025-05-16, under 510(k) number K243105.

Who is the listed applicant for Ruby Intravascular Catheter?

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

What is the FDA product code for Ruby Intravascular Catheter?

The FDA product code for Ruby Intravascular Catheter is FOZ.

Other records listing Venocare, 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.

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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

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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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