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FDA 510(k)

BLADDER RETENTION CATHETERIZATION TRAY

K-Number: K791674 · 1979-11-05

ApplicantLatex Ind., Inc.
Decision Date1979-11-05
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BLADDER RETENTION CATHETERIZATION TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Latex Ind., Inc.. It received FDA 510(k) clearance on 1979-11-05 under 510(k) number K791674. 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 BLADDER RETENTION CATHETERIZATION TRAY?

BLADDER RETENTION CATHETERIZATION TRAY is a medical device that received FDA 510(k) clearance on 1979-11-05. The listed applicant is Latex Ind., Inc.. The 510(k) number is K791674.

When did BLADDER RETENTION CATHETERIZATION TRAY receive FDA 510(k) clearance?

BLADDER RETENTION CATHETERIZATION TRAY received FDA 510(k) clearance on 1979-11-05, under 510(k) number K791674.

Who is the listed applicant for BLADDER RETENTION CATHETERIZATION TRAY?

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

What is the FDA product code for BLADDER RETENTION CATHETERIZATION TRAY?

The FDA product code for BLADDER RETENTION CATHETERIZATION TRAY is KOD.

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Other records listing Latex Ind., 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.

K812058AKRON URINARY DRAINAGE BATK810281UROLOGICAL CATHETERSK781751CATHETER, AKRON FOLEY TEFLONK781433AKRON MALE EXTERNAL CATHETERK772277BLADDER RETENTION-CATHETHERIZATIONTRAYK772341BLADDER KIT - 734000

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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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