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FDA 510(k)

LANDMARK ADD-A-LUMEN CATHETER KIT

K-Number: K912358 · 1992-01-02

ApplicantMenlo Care, Inc.
Decision Date1992-01-02
Product CodeFOZ
Advisory CommitteeHO
DecisionUnknown

Device Summary

LANDMARK ADD-A-LUMEN CATHETER KIT is the device name listed in this FDA 510(k) record. The listed applicant is Menlo Care, Inc.. It received FDA 510(k) clearance on 1992-01-02 under 510(k) number K912358. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the LANDMARK ADD-A-LUMEN CATHETER KIT?

LANDMARK ADD-A-LUMEN CATHETER KIT is a medical device that received FDA 510(k) clearance on 1992-01-02. The listed applicant is Menlo Care, Inc.. The 510(k) number is K912358.

When did LANDMARK ADD-A-LUMEN CATHETER KIT receive FDA 510(k) clearance?

LANDMARK ADD-A-LUMEN CATHETER KIT received FDA 510(k) clearance on 1992-01-02, under 510(k) number K912358.

Who is the listed applicant for LANDMARK ADD-A-LUMEN CATHETER KIT?

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

What is the FDA product code for LANDMARK ADD-A-LUMEN CATHETER KIT?

The FDA product code for LANDMARK ADD-A-LUMEN CATHETER KIT is FOZ.

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Other records listing Menlo Care, 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.

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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