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FDA 510(k)

VERSACATH(TM0 MAINLINE(TM) WITH INTRODUCTION TRAY

K-Number: K910564 · 1991-05-06

ApplicantMenlo Care, Inc.
Decision Date1991-05-06
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VERSACATH(TM0 MAINLINE(TM) WITH INTRODUCTION 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 1991-05-06 under 510(k) number K910564. 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 VERSACATH(TM0 MAINLINE(TM) WITH INTRODUCTION TRAY?

VERSACATH(TM0 MAINLINE(TM) WITH INTRODUCTION TRAY is a medical device that received FDA 510(k) clearance on 1991-05-06. The listed applicant is Menlo Care, Inc.. The 510(k) number is K910564.

When did VERSACATH(TM0 MAINLINE(TM) WITH INTRODUCTION TRAY receive FDA 510(k) clearance?

VERSACATH(TM0 MAINLINE(TM) WITH INTRODUCTION TRAY received FDA 510(k) clearance on 1991-05-06, under 510(k) number K910564.

Who is the listed applicant for VERSACATH(TM0 MAINLINE(TM) WITH INTRODUCTION 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 VERSACATH(TM0 MAINLINE(TM) WITH INTRODUCTION TRAY?

The FDA product code for VERSACATH(TM0 MAINLINE(TM) WITH INTRODUCTION 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 CATHETERK945521CENTERMARK(R) PICC INSERTION TRAY LANDMARK(R) MIDLINE CATHETER PREP TRAYK950737LANDMARK MIDLINE CATHETERK944968LANDMARK MIDLINE CATHETERK943893PERCUTANEOUS GRAINAGE CATHETER

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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.

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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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