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FDA 510(k)

GUARDIANCATHETER-URINARY DRAINAGE CATHETER

K-Number: K063795 · 2007-03-05

ApplicantMarian Medical, Inc.
Decision Date2007-03-05
Product CodeGBM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GUARDIANCATHETER-URINARY DRAINAGE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Marian Medical, Inc.. It received FDA 510(k) clearance on 2007-03-05 under 510(k) number K063795. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GUARDIANCATHETER-URINARY DRAINAGE CATHETER?

GUARDIANCATHETER-URINARY DRAINAGE CATHETER is a medical device that received FDA 510(k) clearance on 2007-03-05. The listed applicant is Marian Medical, Inc.. The 510(k) number is K063795.

When did GUARDIANCATHETER-URINARY DRAINAGE CATHETER receive FDA 510(k) clearance?

GUARDIANCATHETER-URINARY DRAINAGE CATHETER received FDA 510(k) clearance on 2007-03-05, under 510(k) number K063795.

Who is the listed applicant for GUARDIANCATHETER-URINARY DRAINAGE CATHETER?

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

What is the FDA product code for GUARDIANCATHETER-URINARY DRAINAGE CATHETER?

The FDA product code for GUARDIANCATHETER-URINARY DRAINAGE CATHETER is GBM.

Related Clinical Trials

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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Other records listing Marian Medical, 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.

K070048GUARDIAN CATHETER-INFANT URINARY COLLECTION KITK050542MARIAN INFANT FEEDING TUBE (GUARDIANPICC PERCUTANEOUS CENTRAL VENOUS CATHETERK042112INFANT FEEDING TUBE

Related Devices (Code: GBM)

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.

K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter CompactWell Lead Medical Co., Ltd.K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterConvatec LimitedK211436Intermittent Catheter (Not Finalized)Hollister IncorporatedK200820SpeediCath Compact SetColoplastK192904SpeediCath Compact SetColoplastK200142SpeediCath SoftColoplast

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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