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FDA 510(k)

MEDLINE PVC URETHRAL CATHETER

K-Number: K100302 · 2010-07-02

ApplicantMedline Industries, Inc.
Decision Date2010-07-02
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MEDLINE PVC URETHRAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2010-07-02 under 510(k) number K100302. 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 MEDLINE PVC URETHRAL CATHETER?

MEDLINE PVC URETHRAL CATHETER is a medical device that received FDA 510(k) clearance on 2010-07-02. The listed applicant is Medline Industries, Inc.. The 510(k) number is K100302.

When did MEDLINE PVC URETHRAL CATHETER receive FDA 510(k) clearance?

MEDLINE PVC URETHRAL CATHETER received FDA 510(k) clearance on 2010-07-02, under 510(k) number K100302.

Who is the listed applicant for MEDLINE PVC URETHRAL CATHETER?

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

What is the FDA product code for MEDLINE PVC URETHRAL CATHETER?

The FDA product code for MEDLINE PVC URETHRAL CATHETER is EZD.

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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.

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