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FDA 510(k)

CLASSIC INTERMITTENT CATHETER

K-Number: K132619 · 2013-10-11

ApplicantFlexicare Medical, Ltd.
Decision Date2013-10-11
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CLASSIC INTERMITTENT CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Flexicare Medical, Ltd.. It received FDA 510(k) clearance on 2013-10-11 under 510(k) number K132619. 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 CLASSIC INTERMITTENT CATHETER?

CLASSIC INTERMITTENT CATHETER is a medical device that received FDA 510(k) clearance on 2013-10-11. The listed applicant is Flexicare Medical, Ltd.. The 510(k) number is K132619.

When did CLASSIC INTERMITTENT CATHETER receive FDA 510(k) clearance?

CLASSIC INTERMITTENT CATHETER received FDA 510(k) clearance on 2013-10-11, under 510(k) number K132619.

Who is the listed applicant for CLASSIC INTERMITTENT CATHETER?

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

What is the FDA product code for CLASSIC INTERMITTENT CATHETER?

The FDA product code for CLASSIC INTERMITTENT 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.

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Other records listing Flexicare Medical, Ltd. 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.

K092218FLEXICARE BREATHING FILTERSK091591FLEXICARE MEDICAL ENDOTRACHEAL TUBESK951652VENTIMASK MK IV

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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