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FDA 510(k)

Actreen Hi-Lite Intermittent Urinary Catheters

K-Number: K192577 · 2020-05-07

ApplicantB.Braun Medical, Inc.
Decision Date2020-05-07
Product CodeGBM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Actreen Hi-Lite Intermittent Urinary Catheters is the device name listed in this FDA 510(k) record. The listed applicant is B.Braun Medical, Inc.. It received FDA 510(k) clearance on 2020-05-07 under 510(k) number K192577. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Actreen Hi-Lite Intermittent Urinary Catheters?

Actreen Hi-Lite Intermittent Urinary Catheters is a medical device that received FDA 510(k) clearance on 2020-05-07. The listed applicant is B.Braun Medical, Inc.. The 510(k) number is K192577.

When did Actreen Hi-Lite Intermittent Urinary Catheters receive FDA 510(k) clearance?

Actreen Hi-Lite Intermittent Urinary Catheters received FDA 510(k) clearance on 2020-05-07, under 510(k) number K192577.

Who is the listed applicant for Actreen Hi-Lite Intermittent Urinary Catheters?

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

What is the FDA product code for Actreen Hi-Lite Intermittent Urinary Catheters?

The FDA product code for Actreen Hi-Lite Intermittent Urinary Catheters is GBM.

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Related Devices (Code: GBM)

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.

K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter CompactWell Lead Medical Co., Ltd.K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterConvatec LimitedK211436Intermittent Catheter (Not Finalized)Hollister IncorporatedK200820SpeediCath Compact SetColoplastK192904SpeediCath Compact SetColoplastK200142SpeediCath SoftColoplast

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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