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FDA 510(k)

PVC Hydrophilic Urethral Catheter

K-Number: K212567 · 2022-12-07

ApplicantChengdu Daxan Innovative Medical Tech. Co., Ltd.
Decision Date2022-12-07
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Chengdu Daxan Innovative Medical Tech. Co., 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.

K243175Disposable Intermittent Catheter (TPU Catheter)

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.

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).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 IncorporatedK260999LoFric Elle ProWellspect AB

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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