Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CATCO UROLOGICAL CATHETER

K-Number: K944782 · 1994-10-13

ApplicantCatco Medical, Inc.
Decision Date1994-10-13
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CATCO UROLOGICAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Catco Medical, Inc.. It received FDA 510(k) clearance on 1994-10-13 under 510(k) number K944782. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CATCO UROLOGICAL CATHETER?

CATCO UROLOGICAL CATHETER is a medical device that received FDA 510(k) clearance on 1994-10-13. The listed applicant is Catco Medical, Inc.. The 510(k) number is K944782.

When did CATCO UROLOGICAL CATHETER receive FDA 510(k) clearance?

CATCO UROLOGICAL CATHETER received FDA 510(k) clearance on 1994-10-13, under 510(k) number K944782.

Who is the listed applicant for CATCO UROLOGICAL CATHETER?

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

What is the FDA product code for CATCO UROLOGICAL CATHETER?

The FDA product code for CATCO UROLOGICAL CATHETER is EZD.

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 Catco 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.

K945728CATCO THORACIC CATHETERK944336CATCO UMBILICAL VESSEL CATHETERK944367CATCO POLYURETHANE UMBILICAL VESSEL CATHETERK944368CATCO SILICONE UMBILICAL VESSEL CATHETERK944410CATCO SILICONE DUAL LUMEN UMBILICAL VESSEL CATHETERK944504CATCO FIRST PICC

View all 12 devices →

Related Devices (Code: EZD)

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.

K261418Liquick X-treme, Liquick X-treme PlusTeleflex MedicalK260737Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).ConvatecK261658LoFric Origo Pro CoudéWellspect ABK262045Luja SoftColoplast A.S.K260394Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)Hangzhou Jimushi Meditech Co., Ltd.K253295Coude Sleeved IC; Coude Plus Sleeved ICHollister Incorporated

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.

↑