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FDA 510(k)

PEDIATRIC EUROPHYLIC FOLEY CATHETER

K-Number: K954752 · 1995-10-30

ApplicantRegulatory & Marketing Services, Inc.
Decision Date1995-10-30
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PEDIATRIC EUROPHYLIC FOLEY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Regulatory & Marketing Services, Inc.. It received FDA 510(k) clearance on 1995-10-30 under 510(k) number K954752. 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 PEDIATRIC EUROPHYLIC FOLEY CATHETER?

PEDIATRIC EUROPHYLIC FOLEY CATHETER is a medical device that received FDA 510(k) clearance on 1995-10-30. The listed applicant is Regulatory & Marketing Services, Inc.. The 510(k) number is K954752.

When did PEDIATRIC EUROPHYLIC FOLEY CATHETER receive FDA 510(k) clearance?

PEDIATRIC EUROPHYLIC FOLEY CATHETER received FDA 510(k) clearance on 1995-10-30, under 510(k) number K954752.

Who is the listed applicant for PEDIATRIC EUROPHYLIC FOLEY CATHETER?

The FDA 510(k) record lists Regulatory & Marketing Services, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PEDIATRIC EUROPHYLIC FOLEY CATHETER?

The FDA product code for PEDIATRIC EUROPHYLIC FOLEY CATHETER is EZL.

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Other records listing Regulatory & Marketing Services, Inc. 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.

K101721WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULAK944673MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBEK941342PAIN DOCK941543DIAL MEDICAL KITK944384ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAGK944379ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG

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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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