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FDA 510(k)

LATEX FOLEY CATHETER (HYDROMER COATED)

K-Number: K801415 · 1980-08-20

ApplicantG.D. Searle and Co.
Decision Date1980-08-20
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LATEX FOLEY CATHETER (HYDROMER COATED) is the device name listed in this FDA 510(k) record. The listed applicant is G.D. Searle and Co.. It received FDA 510(k) clearance on 1980-08-20 under 510(k) number K801415. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LATEX FOLEY CATHETER (HYDROMER COATED)?

LATEX FOLEY CATHETER (HYDROMER COATED) is a medical device that received FDA 510(k) clearance on 1980-08-20. The listed applicant is G.D. Searle and Co.. The 510(k) number is K801415.

When did LATEX FOLEY CATHETER (HYDROMER COATED) receive FDA 510(k) clearance?

LATEX FOLEY CATHETER (HYDROMER COATED) received FDA 510(k) clearance on 1980-08-20, under 510(k) number K801415.

Who is the listed applicant for LATEX FOLEY CATHETER (HYDROMER COATED)?

The FDA 510(k) record lists G.D. Searle and Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LATEX FOLEY CATHETER (HYDROMER COATED)?

The FDA product code for LATEX FOLEY CATHETER (HYDROMER COATED) is KOD.

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Other records listing G.D. Searle and Co. 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.

K821159IN-LINE OXYGEN MONITORING SYSTEMK811068BYPASS COILK811071VENOUS OXYGEN PROBEK803238INTRAVASCULAR CATHETERK810630SILICONE ELASTOMER COATED LATEX FOLEYK810131ADMINISTRATION SET

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Related Devices (Code: KOD)

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.

K251864Rubber Utility CatheterC.R. Bard, Inc.K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd.K220730allFlex Ureteral Catheters, Krait Ureteral CathetersAllwin Medical Devices, Inc.K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc.K180354UroGen Ureteral CatheterUrogen Pharma, Ltd.

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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