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FDA 510(k)

CENTERMARK(R) PICC INSERTION TRAY LANDMARK(R) MIDLINE CATHETER PREP TRAY

K-Number: K945521 · 1995-04-06

ApplicantMenlo Care, Inc.
Decision Date1995-04-06
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CENTERMARK(R) PICC INSERTION TRAY LANDMARK(R) MIDLINE CATHETER PREP TRAY 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 1995-04-06 under 510(k) number K945521. 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 CENTERMARK(R) PICC INSERTION TRAY LANDMARK(R) MIDLINE CATHETER PREP TRAY?

CENTERMARK(R) PICC INSERTION TRAY LANDMARK(R) MIDLINE CATHETER PREP TRAY is a medical device that received FDA 510(k) clearance on 1995-04-06. The listed applicant is Menlo Care, Inc.. The 510(k) number is K945521.

When did CENTERMARK(R) PICC INSERTION TRAY LANDMARK(R) MIDLINE CATHETER PREP TRAY receive FDA 510(k) clearance?

CENTERMARK(R) PICC INSERTION TRAY LANDMARK(R) MIDLINE CATHETER PREP TRAY received FDA 510(k) clearance on 1995-04-06, under 510(k) number K945521.

Who is the listed applicant for CENTERMARK(R) PICC INSERTION TRAY LANDMARK(R) MIDLINE CATHETER PREP TRAY?

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 CENTERMARK(R) PICC INSERTION TRAY LANDMARK(R) MIDLINE CATHETER PREP TRAY?

The FDA product code for CENTERMARK(R) PICC INSERTION TRAY LANDMARK(R) MIDLINE CATHETER PREP TRAY is FOZ.

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Other records listing Menlo Care, 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.

K964447PICC CATHETER/MIDLINE CATHETERK951620MIDMARK MIDLINE CATHETERK950737LANDMARK MIDLINE CATHETERK944968LANDMARK MIDLINE CATHETERK943893PERCUTANEOUS GRAINAGE CATHETERK943143BILIARY STENT

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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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