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FDA 510(k)

CLOSED SYSTEM FOLEY CATHERIZATION PROCED

K-Number: K791598 · 1979-11-16

ApplicantWalpak Co.
Decision Date1979-11-16
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CLOSED SYSTEM FOLEY CATHERIZATION PROCED is the device name listed in this FDA 510(k) record. The listed applicant is Walpak Co.. It received FDA 510(k) clearance on 1979-11-16 under 510(k) number K791598. 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 CLOSED SYSTEM FOLEY CATHERIZATION PROCED?

CLOSED SYSTEM FOLEY CATHERIZATION PROCED is a medical device that received FDA 510(k) clearance on 1979-11-16. The listed applicant is Walpak Co.. The 510(k) number is K791598.

When did CLOSED SYSTEM FOLEY CATHERIZATION PROCED receive FDA 510(k) clearance?

CLOSED SYSTEM FOLEY CATHERIZATION PROCED received FDA 510(k) clearance on 1979-11-16, under 510(k) number K791598.

Who is the listed applicant for CLOSED SYSTEM FOLEY CATHERIZATION PROCED?

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

What is the FDA product code for CLOSED SYSTEM FOLEY CATHERIZATION PROCED?

The FDA product code for CLOSED SYSTEM FOLEY CATHERIZATION PROCED is KOD.

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Other records listing Walpak 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.

K803200IRRIGATION SET W/BULB SYRINGEK803204IRRIGATION PISTONK803198IRRIGATION SET W/PISTON SYRINGEK803199SUTURE REMOVAL KITK803201LEMON GLYCERINE SWABSK802083CATHETER INSERTION TRAY

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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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