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FDA 510(k)

Liv Pre-lubricated Intermittent Catheter

K-Number: K260502 · 2026-03-12

ApplicantHR Healthcare
Decision Date2026-03-12
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Liv Pre-lubricated Intermittent Catheter is a medical device manufactured by HR Healthcare. It received FDA 510(k) clearance on 2026-03-12 under approval number K260502. 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 Liv Pre-lubricated Intermittent Catheter?

Liv Pre-lubricated Intermittent Catheter is a medical device that received FDA 510(k) clearance on 2026-03-12. It is manufactured by HR Healthcare. The 510(k) number is K260502.

When was Liv Pre-lubricated Intermittent Catheter approved by the FDA?

Liv Pre-lubricated Intermittent Catheter received FDA 510(k) clearance on 2026-03-12, under approval number K260502.

What company makes Liv Pre-lubricated Intermittent Catheter?

Liv Pre-lubricated Intermittent Catheter is manufactured by HR Healthcare.

What is the FDA product code for Liv Pre-lubricated Intermittent Catheter?

The FDA product code for Liv Pre-lubricated Intermittent Catheter is EZD.

Related Clinical Trials

NCT07179705 Using a Hypotension Prediction Index to Prevent Low Blood Pressure During Dialysis in ICU Patients RECRUITING

Other Devices by HR Healthcare

K251274EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits

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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