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FDA 510(k)

FOLEY CATHETER

K-Number: K803079 · 1980-12-22

ApplicantAmerican Hospital Supply Corp.
Decision Date1980-12-22
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FOLEY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is American Hospital Supply Corp.. It received FDA 510(k) clearance on 1980-12-22 under 510(k) number K803079. 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 FOLEY CATHETER?

FOLEY CATHETER is a medical device that received FDA 510(k) clearance on 1980-12-22. The listed applicant is American Hospital Supply Corp.. The 510(k) number is K803079.

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

FOLEY CATHETER received FDA 510(k) clearance on 1980-12-22, under 510(k) number K803079.

Who is the listed applicant for FOLEY CATHETER?

The FDA 510(k) record lists American Hospital Supply Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FOLEY CATHETER?

The FDA product code for FOLEY CATHETER is KOD.

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Other records listing American Hospital Supply Corp. 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.

K854739AMERICAN STERILE SURGICAL ABSORBENT TOWELK854759AMERICAN STERILE MAYO STAND TRAYK832826AAP DOSIMETRY RELEASE OR BASIN SETSK830546DOSIMETRIC RELEASEK822990CONVERTORS PRIMARY WOUND DRESSING IIK830343CONTAINER W/PRIMING SOLUTION

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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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