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FDA 510(k)

AMSure Hydrophilic Intermittent Catheter

K-Number: K181445 · 2018-10-01

ApplicantAmsino International, Inc.
Decision Date2018-10-01
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AMSure Hydrophilic Intermittent Catheter is a medical device manufactured by Amsino International, Inc.. It received FDA 510(k) clearance on 2018-10-01 under approval number K181445. 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 AMSure Hydrophilic Intermittent Catheter?

AMSure Hydrophilic Intermittent Catheter is a medical device that received FDA 510(k) clearance on 2018-10-01. It is manufactured by Amsino International, Inc.. The 510(k) number is K181445.

When was AMSure Hydrophilic Intermittent Catheter approved by the FDA?

AMSure Hydrophilic Intermittent Catheter received FDA 510(k) clearance on 2018-10-01, under approval number K181445.

What company makes AMSure Hydrophilic Intermittent Catheter?

AMSure Hydrophilic Intermittent Catheter is manufactured by Amsino International, Inc..

What is the FDA product code for AMSure Hydrophilic Intermittent Catheter?

The FDA product code for AMSure Hydrophilic Intermittent Catheter is EZD.

Related Clinical Trials

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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. K180738COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary CatheterCompactcath, 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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