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FDA 510(k)

EUROMEDICAL HAEMATURIA FOLEY CATHETER

K-Number: K973076 · 1998-09-16

ApplicantUnomedical Sdn Bhd
Decision Date1998-09-16
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EUROMEDICAL HAEMATURIA FOLEY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Unomedical Sdn Bhd. It received FDA 510(k) clearance on 1998-09-16 under 510(k) number K973076. 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 EUROMEDICAL HAEMATURIA FOLEY CATHETER?

EUROMEDICAL HAEMATURIA FOLEY CATHETER is a medical device that received FDA 510(k) clearance on 1998-09-16. The listed applicant is Unomedical Sdn Bhd. The 510(k) number is K973076.

When did EUROMEDICAL HAEMATURIA FOLEY CATHETER receive FDA 510(k) clearance?

EUROMEDICAL HAEMATURIA FOLEY CATHETER received FDA 510(k) clearance on 1998-09-16, under 510(k) number K973076.

Who is the listed applicant for EUROMEDICAL HAEMATURIA FOLEY CATHETER?

The FDA 510(k) record lists Unomedical Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EUROMEDICAL HAEMATURIA FOLEY CATHETER?

The FDA product code for EUROMEDICAL HAEMATURIA FOLEY CATHETER is EZL.

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Other records listing Unomedical Sdn Bhd 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.

K962389EUROMEDICAL REINFORCED ENDOTRACHEAL TUBEK954753PEDIATRIC SILICONE ENDOTRACHEAL TUBEK954750PEDIATRIC WIRE REINFORCED SILICONE ENDOTRACHEAL TUBEK954751SILICONE ENDOTRACHEAL TUBEK954754WIRE REINFORCED SILICONE ENDOTRACHEAL TUBEK951696ENDOTRACHEAL TUBE

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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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