FDA 510(k)

PVC Hydrophilic Urethral Catheter

Número K: K212567 · 2022-12-07

RequerenteChengdu Daxan Innovative Medical Tech. Co., Ltd.

Data da decisão2022-12-07

Código do produtoEZD

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

PVC Hydrophilic Urethral Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Chengdu Daxan Innovative Medical Tech. Co., Ltd.. It received FDA 510(k) clearance on 2022-12-07 under 510(k) number K212567. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PVC Hydrophilic Urethral Catheter?

PVC Hydrophilic Urethral Catheter is a medical device that received FDA 510(k) clearance on 2022-12-07. The listed applicant is Chengdu Daxan Innovative Medical Tech. Co., Ltd.. The 510(k) number is K212567.

When did PVC Hydrophilic Urethral Catheter receive FDA 510(k) clearance?

PVC Hydrophilic Urethral Catheter received FDA 510(k) clearance on 2022-12-07, under 510(k) number K212567.

Who is the listed applicant for PVC Hydrophilic Urethral Catheter?

The FDA 510(k) record lists Chengdu Daxan Innovative Medical Tech. Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PVC Hydrophilic Urethral Catheter?

The FDA product code for PVC Hydrophilic Urethral Catheter is EZD.

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Dispositivos Relacionados (Código: EZD)

K261418Liquick X-treme, Liquick X-treme PlusTeleflex Medical K260737Cure 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).Convatec K261658LoFric Origo Pro CoudéWellspect AB K262045Luja 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

Fonte oficial

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