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FDA 510(k)

DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER

K-Number: K024010 · 2003-06-11

ApplicantThe Kendall Company Div. of Tyco Healthcare Group
Decision Date2003-06-11
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is The Kendall Company Div. of Tyco Healthcare Group. It received FDA 510(k) clearance on 2003-06-11 under 510(k) number K024010. 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 DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER?

DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER is a medical device that received FDA 510(k) clearance on 2003-06-11. The listed applicant is The Kendall Company Div. of Tyco Healthcare Group. The 510(k) number is K024010.

When did DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER receive FDA 510(k) clearance?

DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER received FDA 510(k) clearance on 2003-06-11, under 510(k) number K024010.

Who is the listed applicant for DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER?

The FDA 510(k) record lists The Kendall Company Div. of Tyco Healthcare Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER?

The FDA product code for DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER is EZL.

Related Clinical Trials

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Other records listing The Kendall Company Div. of Tyco Healthcare Group 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.

K831081EZEE FILTER/SEPARATORK831082CONNECTING TUBINGK831079LIQUIPETTE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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