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FDA 510(k)

AMSURE HYDROPHILIC LATEX FOLEY CATHETER

K-Number: K091699 · 2009-08-10

ApplicantAmsino International, Inc.
Decision Date2009-08-10
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AMSURE HYDROPHILIC LATEX FOLEY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Amsino International, Inc.. It received FDA 510(k) clearance on 2009-08-10 under 510(k) number K091699. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMSURE HYDROPHILIC LATEX FOLEY CATHETER?

AMSURE HYDROPHILIC LATEX FOLEY CATHETER is a medical device that received FDA 510(k) clearance on 2009-08-10. The listed applicant is Amsino International, Inc.. The 510(k) number is K091699.

When did AMSURE HYDROPHILIC LATEX FOLEY CATHETER receive FDA 510(k) clearance?

AMSURE HYDROPHILIC LATEX FOLEY CATHETER received FDA 510(k) clearance on 2009-08-10, under 510(k) number K091699.

Who is the listed applicant for AMSURE HYDROPHILIC LATEX FOLEY CATHETER?

The FDA 510(k) record lists Amsino International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMSURE HYDROPHILIC LATEX FOLEY CATHETER?

The FDA product code for AMSURE HYDROPHILIC LATEX FOLEY CATHETER is EZL.

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Other records listing Amsino International, Inc. as applicant

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Related Devices (Code: EZL)

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.

K260756TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)Sentinel Medical Technologies,K262056Rusch Latex Gold Foley CatheterTeleflex Medical Sdn. Bhd.K252537Rusch SoftSimplastic Foley CathetersTeleflex Medical Sdn. Bhd.K243011Silicone Urethral Catheter (Silicone Urethral Catheter)Guangdong Ecan Medical Co., Ltd.K241424InnoCare Specialty Foley CatheterInnocare Urologics, LLCK232469Rüsch Latex Gold Foley CatheterTeleflexmedical, 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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