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FDA 510(k)

UROLOGICAL CATHETER

K-Number: K881646 · 1988-06-16

ApplicantCoeur Laboratories, Inc.
Decision Date1988-06-16
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UROLOGICAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Coeur Laboratories, Inc.. It received FDA 510(k) clearance on 1988-06-16 under 510(k) number K881646. 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 UROLOGICAL CATHETER?

UROLOGICAL CATHETER is a medical device that received FDA 510(k) clearance on 1988-06-16. The listed applicant is Coeur Laboratories, Inc.. The 510(k) number is K881646.

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

UROLOGICAL CATHETER received FDA 510(k) clearance on 1988-06-16, under 510(k) number K881646.

Who is the listed applicant for UROLOGICAL CATHETER?

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

What is the FDA product code for UROLOGICAL CATHETER?

The FDA product code for UROLOGICAL CATHETER is KOD.

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Other records listing Coeur Laboratories, Inc. 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.

K971712COEUR 130 ML ANGIOGRAPHIC SYRINGEK965214COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002)K960965FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211K890292PCA-10, 10CC DISP. ANGIOGRAPHY CONTROL SYRINGEK885138CAPILLARY TUBE, BLOOD COLLECTIONK88520216 LONG CATHETER W/ADAPTER, 14 FR AND 12 FR

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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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