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FDA 510(k)

MODIFIED PRISTINE CULTURE CATHETER

K-Number: K893390 · 1989-09-07

ApplicantHml Medical, Inc.
Decision Date1989-09-07
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODIFIED PRISTINE CULTURE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Hml Medical, Inc.. It received FDA 510(k) clearance on 1989-09-07 under 510(k) number K893390. 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 MODIFIED PRISTINE CULTURE CATHETER?

MODIFIED PRISTINE CULTURE CATHETER is a medical device that received FDA 510(k) clearance on 1989-09-07. The listed applicant is Hml Medical, Inc.. The 510(k) number is K893390.

When did MODIFIED PRISTINE CULTURE CATHETER receive FDA 510(k) clearance?

MODIFIED PRISTINE CULTURE CATHETER received FDA 510(k) clearance on 1989-09-07, under 510(k) number K893390.

Who is the listed applicant for MODIFIED PRISTINE CULTURE CATHETER?

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

What is the FDA product code for MODIFIED PRISTINE CULTURE CATHETER?

The FDA product code for MODIFIED PRISTINE CULTURE CATHETER is KOD.

Related Clinical Trials

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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

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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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