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FDA 510(k)

Perifix and Contiplex Catheter

K-Number: K153297 · 2016-08-12

ApplicantB.Braun Medical, Inc.
Decision Date2016-08-12
Product CodeBSO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Perifix and Contiplex Catheter 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 2016-08-12 under 510(k) number K153297. 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 Perifix and Contiplex Catheter?

Perifix and Contiplex Catheter is a medical device that received FDA 510(k) clearance on 2016-08-12. The listed applicant is B.Braun Medical, Inc.. The 510(k) number is K153297.

When did Perifix and Contiplex Catheter receive FDA 510(k) clearance?

Perifix and Contiplex Catheter received FDA 510(k) clearance on 2016-08-12, under 510(k) number K153297.

Who is the listed applicant for Perifix and Contiplex Catheter?

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 Perifix and Contiplex Catheter?

The FDA product code for Perifix and Contiplex Catheter is BSO.

Other records listing B.Braun Medical, Inc. as applicant

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.

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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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