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FDA 510(k)

ARGYLE HEMATURIA BALLOON CATHETER

K-Number: K802875 · 1980-12-16

ApplicantSherwood Medical Co.
Decision Date1980-12-16
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ARGYLE HEMATURIA BALLOON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Sherwood Medical Co.. It received FDA 510(k) clearance on 1980-12-16 under 510(k) number K802875. 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 ARGYLE HEMATURIA BALLOON CATHETER?

ARGYLE HEMATURIA BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 1980-12-16. The listed applicant is Sherwood Medical Co.. The 510(k) number is K802875.

When did ARGYLE HEMATURIA BALLOON CATHETER receive FDA 510(k) clearance?

ARGYLE HEMATURIA BALLOON CATHETER received FDA 510(k) clearance on 1980-12-16, under 510(k) number K802875.

Who is the listed applicant for ARGYLE HEMATURIA BALLOON CATHETER?

The FDA 510(k) record lists Sherwood Medical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARGYLE HEMATURIA BALLOON CATHETER?

The FDA product code for ARGYLE HEMATURIA BALLOON CATHETER is KOD.

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Other records listing Sherwood Medical 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.

K981365MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONSK960982MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULAK962880SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEMK960574ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEMK960677KANGAROO JEJUNAL FEEDING SYSTEMK960632KANGAROO FEEDING TUBE PLACMENT STYLET

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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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