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FDA 510(k)

DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC

K-Number: K103086 · 2011-06-07

ApplicantDynarex Corporation
Decision Date2011-06-07
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC is the device name listed in this FDA 510(k) record. The listed applicant is Dynarex Corporation. It received FDA 510(k) clearance on 2011-06-07 under 510(k) number K103086. 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 DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC?

DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC is a medical device that received FDA 510(k) clearance on 2011-06-07. The listed applicant is Dynarex Corporation. The 510(k) number is K103086.

When did DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC receive FDA 510(k) clearance?

DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC received FDA 510(k) clearance on 2011-06-07, under 510(k) number K103086.

Who is the listed applicant for DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC?

The FDA 510(k) record lists Dynarex Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC?

The FDA product code for DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC is EZD.

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Other records listing Dynarex Corporation 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.

K172266Dynarex Three-Way StopcockK152970Dynarex Xeroform Petrolatum DressingK102637DYNAREX ULTRASOUND GELK092488DYNAREX STERILE LUBRICATING JELLYK082863DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE (1000ML)K081569DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR USE WITH CHEMOTHERAPY DRUGS

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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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