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FDA 510(k)

Introcan Safety 3 Closed IV Catheter

K-Number: K213085 · 2021-10-25

ApplicantB.Braun Medical, Inc.
Decision Date2021-10-25
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Introcan Safety 3 Closed IV Catheter is a medical device manufactured by B.Braun Medical, Inc.. It received FDA 510(k) clearance on 2021-10-25 under approval number K213085. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Introcan Safety 3 Closed IV Catheter?

Introcan Safety 3 Closed IV Catheter is a medical device that received FDA 510(k) clearance on 2021-10-25. It is manufactured by B.Braun Medical, Inc.. The 510(k) number is K213085.

When was Introcan Safety 3 Closed IV Catheter approved by the FDA?

Introcan Safety 3 Closed IV Catheter received FDA 510(k) clearance on 2021-10-25, under approval number K213085.

What company makes Introcan Safety 3 Closed IV Catheter?

Introcan Safety 3 Closed IV Catheter is manufactured by B.Braun Medical, Inc..

What is the FDA product code for Introcan Safety 3 Closed IV Catheter?

The FDA product code for Introcan Safety 3 Closed IV Catheter is FOZ.

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Related Devices (Code: FOZ)

K162894AccuCath Intravascular CatheterC.R. Bard, Inc. K161779MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV CatheterMedsource International, LLC K162377PowerGlide Pro Midline CatheterC.R. Bard, Inc. K161866BioFlo Midline CatheterNavilyst Medical, Inc. K161777BD Nexiva and BD Nexiva Diffusics Closed IV Catheter SystemsBecton Dickinson Infusion Therapy Systems, Inc. K160592SUPERCATH 6Togo Medikit Co., Ltd.

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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