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FDA 510(k)

Disposable Intermittent Catheter (TPU Catheter)

K-Number: K243175 · 2025-06-26

ApplicantChengdu Daxan Innovative Medical Tech. Co., Ltd.
Decision Date2025-06-26
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Intermittent Catheter (TPU Catheter) is a medical device manufactured by Chengdu Daxan Innovative Medical Tech. Co., Ltd.. It received FDA 510(k) clearance on 2025-06-26 under approval number K243175. 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 Disposable Intermittent Catheter (TPU Catheter)?

Disposable Intermittent Catheter (TPU Catheter) is a medical device that received FDA 510(k) clearance on 2025-06-26. It is manufactured by Chengdu Daxan Innovative Medical Tech. Co., Ltd.. The 510(k) number is K243175.

When was Disposable Intermittent Catheter (TPU Catheter) approved by the FDA?

Disposable Intermittent Catheter (TPU Catheter) received FDA 510(k) clearance on 2025-06-26, under approval number K243175.

What company makes Disposable Intermittent Catheter (TPU Catheter)?

Disposable Intermittent Catheter (TPU Catheter) is manufactured by Chengdu Daxan Innovative Medical Tech. Co., Ltd..

What is the FDA product code for Disposable Intermittent Catheter (TPU Catheter)?

The FDA product code for Disposable Intermittent Catheter (TPU Catheter) is EZD.

Related Clinical Trials

NCT07179705 Using a Hypotension Prediction Index to Prevent Low Blood Pressure During Dialysis in ICU Patients RECRUITING NCT07539701 An Initial Experience With the Disposable Celsio Cryocatheter System for Diagnostic and Interventional Bronchoscopy NOT_YET_RECRUITING NCT07273877 "Real-world Assessment of BP Control in Patients With Hypertension by the Netrod RDN System" - REACH-RDN ENROLLING_BY_INVITATION

Other Devices by Chengdu Daxan Innovative Medical Tech. Co., Ltd.

K212567PVC Hydrophilic Urethral Catheter

Related Devices (Code: EZD)

K161445PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro CAdapta Medical, Inc. K160858CompactCath Intermittent Urinary CatheterCompactcath, Inc. K151745FULL CARE Disposable PVC Nelaton CatheterShaoxing Fuqing Health Products Co., Ltd. K170233Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter)Zhanjiang Star Enterprise Co., Ltd. K172247Magic3 Go Intermittent Urinary CatheterC.R. Bard, Inc. K181445AMSure Hydrophilic Intermittent CatheterAmsino International, Inc.

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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