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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 a medical device manufactured by B.Braun Medical, Inc.. It received FDA 510(k) clearance on 2020-05-07 under approval 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. It is manufactured by B.Braun Medical, Inc.. The 510(k) number is K192577.

When was Actreen Hi-Lite Intermittent Urinary Catheters approved by the FDA?

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

What company makes Actreen Hi-Lite Intermittent Urinary Catheters?

Actreen Hi-Lite Intermittent Urinary Catheters is manufactured by B.Braun Medical, Inc..

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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Other Devices by B.Braun Medical, Inc.

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Related Devices (Code: GBM)

K161672SpeediCath Flex CoudeColoplast Corp. K160795United Urologics Intermittent CatheterRobling Medical K151772Actreen Mini Intermittent Urinary CathetersB.Braun Medical, Inc. K172278Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral StentCook Incorporated K163179Onli Intermittent CatheterHollister Incorporated K183253ValPro 2 Plus, VaPro 2 Plus PocketHollister Incorporated

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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