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FDA 510(k)

SYMPACATH HYDROGEL COATED FOLEY

K-Number: K964575 · 1997-02-04

ApplicantRusch Intl.
Decision Date1997-02-04
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SYMPACATH HYDROGEL COATED FOLEY is the device name listed in this FDA 510(k) record. The listed applicant is Rusch Intl.. It received FDA 510(k) clearance on 1997-02-04 under 510(k) number K964575. 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 SYMPACATH HYDROGEL COATED FOLEY?

SYMPACATH HYDROGEL COATED FOLEY is a medical device that received FDA 510(k) clearance on 1997-02-04. The listed applicant is Rusch Intl.. The 510(k) number is K964575.

When did SYMPACATH HYDROGEL COATED FOLEY receive FDA 510(k) clearance?

SYMPACATH HYDROGEL COATED FOLEY received FDA 510(k) clearance on 1997-02-04, under 510(k) number K964575.

Who is the listed applicant for SYMPACATH HYDROGEL COATED FOLEY?

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

What is the FDA product code for SYMPACATH HYDROGEL COATED FOLEY?

The FDA product code for SYMPACATH HYDROGEL COATED FOLEY is EZL.

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Other records listing Rusch Intl. 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.

K033023INTERMITTENT URETHRAL CATHETERSK030559RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEMK023666RUSCH GUIDED CHOLANGIOGRAPHY CATHETERK023918RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESSK023964RUSCH MICROLARYNGEAL TUBEK021540RUSCH EDGAR 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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