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FDA 510(k)

GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT

K-Number: K070048 · 2007-03-15

ApplicantMarian Medical, Inc.
Decision Date2007-03-15
Product CodeFCM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT 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 2007-03-15 under 510(k) number K070048. The device is classified under product code FCM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT?

GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT is a medical device that received FDA 510(k) clearance on 2007-03-15. The listed applicant is Marian Medical, Inc.. The 510(k) number is K070048.

When did GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT receive FDA 510(k) clearance?

GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT received FDA 510(k) clearance on 2007-03-15, under 510(k) number K070048.

Who is the listed applicant for GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT?

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 GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT?

The FDA product code for GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT is FCM.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K063795GUARDIANCATHETER-URINARY DRAINAGE CATHETERK050542MARIAN INFANT FEEDING TUBE (GUARDIANPICC PERCUTANEOUS CENTRAL VENOUS CATHETERK042112INFANT FEEDING TUBE

Related Devices (Code: FCM)

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.

K254076BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter KitC.R. Bard, Inc.K250891Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14CConvatec LimitedK223821Self-Cath Closed SystemColoplastK082831AMSELF CLOSED CATHETERIZATION SYSTEMAmsino International, Inc.K070939SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEMColoplast Manufacturing Us, LLCK030712AMSURE URETHRAL CATHETERIZATION TRAYAmsino International, Inc.

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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