FDA 510(k)

HYDROGEL-COATED URETHRAL CATHETERS AND DRAINS

K-Number: K910197 · 1991-08-09

Decision Date1991-08-09

Product CodeEZC

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

HYDROGEL-COATED URETHRAL CATHETERS AND DRAINS is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 1991-08-09 under 510(k) number K910197. The device is classified under product code EZC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDROGEL-COATED URETHRAL CATHETERS AND DRAINS?

HYDROGEL-COATED URETHRAL CATHETERS AND DRAINS is a medical device that received FDA 510(k) clearance on 1991-08-09. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K910197.

When did HYDROGEL-COATED URETHRAL CATHETERS AND DRAINS receive FDA 510(k) clearance?

HYDROGEL-COATED URETHRAL CATHETERS AND DRAINS received FDA 510(k) clearance on 1991-08-09, under 510(k) number K910197.

Who is the listed applicant for HYDROGEL-COATED URETHRAL CATHETERS AND DRAINS?

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

What is the FDA product code for HYDROGEL-COATED URETHRAL CATHETERS AND DRAINS?

The FDA product code for HYDROGEL-COATED URETHRAL CATHETERS AND DRAINS is EZC.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing C.R. Bard, Inc. as applicant

K253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)K254076BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit K252971Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)K251864Rubber Utility Catheter K251186Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)K241334Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter,

View all 616 devices →

Related Devices (Code: EZC)

K222279Rusch Intermittent Urethral CathetersTeleflex Medical K173596Rusch Intermittent Urethral CathetersTeleflex Medical K946282UNIVERSAL URETHRAL CATHETERLouisville Laboratories, Inc.K913341BARD(R) COUDE TIP TEMPERATURE SENSING CATHETERC.R. Bard, Inc.K910846BARD LATEX URINARY CATHETERS DRAINS- DESIGNS MODIFC.R. Bard, Inc.K910195BARD HYDROGEL-COATED FOLEY CATHETERSC.R. Bard, 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.