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FDA 510(k)

Actreen Mini Intermittent Urinary Catheters

K-Number: K151772 · 2016-02-09

ApplicantB.Braun Medical, Inc.
Decision Date2016-02-09
Product CodeGBM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Actreen Mini Intermittent Urinary Catheters is a medical device manufactured by B.Braun Medical, Inc.. It received FDA 510(k) clearance on 2016-02-09 under approval number K151772. 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 Mini Intermittent Urinary Catheters?

Actreen Mini Intermittent Urinary Catheters is a medical device that received FDA 510(k) clearance on 2016-02-09. It is manufactured by B.Braun Medical, Inc.. The 510(k) number is K151772.

When was Actreen Mini Intermittent Urinary Catheters approved by the FDA?

Actreen Mini Intermittent Urinary Catheters received FDA 510(k) clearance on 2016-02-09, under approval number K151772.

What company makes Actreen Mini Intermittent Urinary Catheters?

Actreen Mini Intermittent Urinary Catheters is manufactured by B.Braun Medical, Inc..

What is the FDA product code for Actreen Mini Intermittent Urinary Catheters?

The FDA product code for Actreen Mini 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 K172278Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral StentCook Incorporated K163179Onli Intermittent CatheterHollister Incorporated K183253ValPro 2 Plus, VaPro 2 Plus PocketHollister Incorporated K180801Actreen Hi-Lite Cath, Actreen Hi-Lite SetB.Braun Medical, Inc.

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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