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FDA 510(k)

B. Braun Tear-Away Introducer Needle

K-Number: K171584 · 2017-12-22

ApplicantB.Braun Medical, Inc.
Decision Date2017-12-22
Product CodeBSO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

B. Braun Tear-Away Introducer Needle is a medical device manufactured by B.Braun Medical, Inc.. It received FDA 510(k) clearance on 2017-12-22 under approval number K171584. The device is classified under product code BSO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the B. Braun Tear-Away Introducer Needle?

B. Braun Tear-Away Introducer Needle is a medical device that received FDA 510(k) clearance on 2017-12-22. It is manufactured by B.Braun Medical, Inc.. The 510(k) number is K171584.

When was B. Braun Tear-Away Introducer Needle approved by the FDA?

B. Braun Tear-Away Introducer Needle received FDA 510(k) clearance on 2017-12-22, under approval number K171584.

What company makes B. Braun Tear-Away Introducer Needle?

B. Braun Tear-Away Introducer Needle is manufactured by B.Braun Medical, Inc..

What is the FDA product code for B. Braun Tear-Away Introducer Needle?

The FDA product code for B. Braun Tear-Away Introducer Needle is BSO.

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Related Devices (Code: BSO)

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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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