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FDA 510(k)

BIO-GUARD AB COATED CATHETER

K-Number: K863354 · 1986-11-04

ApplicantCook Urological, Inc.
Decision Date1986-11-04
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BIO-GUARD AB COATED CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Cook Urological, Inc.. It received FDA 510(k) clearance on 1986-11-04 under 510(k) number K863354. 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 BIO-GUARD AB COATED CATHETER?

BIO-GUARD AB COATED CATHETER is a medical device that received FDA 510(k) clearance on 1986-11-04. The listed applicant is Cook Urological, Inc.. The 510(k) number is K863354.

When did BIO-GUARD AB COATED CATHETER receive FDA 510(k) clearance?

BIO-GUARD AB COATED CATHETER received FDA 510(k) clearance on 1986-11-04, under 510(k) number K863354.

Who is the listed applicant for BIO-GUARD AB COATED CATHETER?

The FDA 510(k) record lists Cook Urological, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIO-GUARD AB COATED CATHETER?

The FDA product code for BIO-GUARD AB COATED CATHETER is KOD.

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Other records listing Cook Urological, Inc. as applicant

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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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