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FDA 510(k)

PRISTINE CULTURE CATHETER

K-Number: K860325 · 1986-08-19

ApplicantHall/Mccollum Laboratories, Inc.
Decision Date1986-08-19
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PRISTINE CULTURE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Hall/Mccollum Laboratories, Inc.. It received FDA 510(k) clearance on 1986-08-19 under 510(k) number K860325. 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 PRISTINE CULTURE CATHETER?

PRISTINE CULTURE CATHETER is a medical device that received FDA 510(k) clearance on 1986-08-19. The listed applicant is Hall/Mccollum Laboratories, Inc.. The 510(k) number is K860325.

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

PRISTINE CULTURE CATHETER received FDA 510(k) clearance on 1986-08-19, under 510(k) number K860325.

Who is the listed applicant for PRISTINE CULTURE CATHETER?

The FDA 510(k) record lists Hall/Mccollum Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRISTINE CULTURE CATHETER?

The FDA product code for PRISTINE CULTURE CATHETER 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 Hall/Mccollum Laboratories, 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.

K862098PRISTINE/BLOOMING/PRISTINE BLOOMING CULTURE CATH

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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