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510(k) K946282

Device
UNIVERSAL URETHRAL CATHETER
Applicant
LOUISVILLE LABORATORIES, INC.
510(k) number
K946282
Product code
EZC  
Decision
Substantially Equivalent (SESE)
Decision date
1995-03-31
Date received
1994-12-27
Regulation
876.5130
Classification name
Catheter, Coude
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DAVID PHELPS
Address
2400 Crittenden Dr. Louisville KY US 40217 40217

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EZC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K222279Rusch Intermittent Urethral CathetersTeleflex Medical2022-08-29
K173596Rusch Intermittent Urethral CathetersTeleflex Medical2018-01-29
K913341BARD(R) COUDE TIP TEMPERATURE SENSING CATHETERC.R. Bard, Inc.1992-01-27
K910846BARD LATEX URINARY CATHETERS DRAINS- DESIGNS MODIFC.R. Bard, Inc.1991-08-16
K910195BARD HYDROGEL-COATED FOLEY CATHETERSC.R. Bard, Inc.1991-08-09
K910197HYDROGEL-COATED URETHRAL CATHETERS AND DRAINSC.R. Bard, Inc.1991-08-09

Legacy Summary#

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FDA Review#

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