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FDA 510(k)

CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT

K-Number: K032710 · 2004-01-09

ApplicantApogee Medical, Inc.
Decision Date2004-01-09
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Apogee Medical, Inc.. It received FDA 510(k) clearance on 2004-01-09 under 510(k) number K032710. 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 INTERMITTENT CATHETERIZATION KIT?

CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT is a medical device that received FDA 510(k) clearance on 2004-01-09. The listed applicant is Apogee Medical, Inc.. The 510(k) number is K032710.

When did CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT receive FDA 510(k) clearance?

CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT received FDA 510(k) clearance on 2004-01-09, under 510(k) number K032710.

Who is the listed applicant for CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT?

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

What is the FDA product code for CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT?

The FDA product code for CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT is KOD.

Related Clinical Trials

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.

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Other records listing Apogee Medical, 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.

K011552UROLOGICAL CATHETER

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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