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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 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 2017-12-22 under 510(k) 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. The listed applicant is B.Braun Medical, Inc.. The 510(k) number is K171584.

When did B. Braun Tear-Away Introducer Needle receive FDA 510(k) clearance?

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

Who is the listed applicant for B. Braun Tear-Away Introducer Needle?

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 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)

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.

K241410EDEN ControlCathJmt Co., Ltd.K231242Perifix FX Catheter; Contiplex FX CatheterB.Braun Medical, Inc.K230603Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002)Teleflex MedicalK193664SubQKath Catheter and Needle SetHk SurgicalK200624Percutaneous IntroducerEpimed International, Inc.K191470C-CAT Anaesthesia Catheter kitCimpax Aps

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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