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FDA 510(k)

CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System

K-Number: K242429 · 2025-04-09

ApplicantBecton Dickinson Inc. (Bd)
Decision Date2025-04-09
Product CodeSEF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System is the device name listed in this FDA 510(k) record. The listed applicant is Becton Dickinson Inc. (Bd). It received FDA 510(k) clearance on 2025-04-09 under 510(k) number K242429. The device is classified under product code SEF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System?

CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System is a medical device that received FDA 510(k) clearance on 2025-04-09. The listed applicant is Becton Dickinson Inc. (Bd). The 510(k) number is K242429.

When did CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System receive FDA 510(k) clearance?

CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System received FDA 510(k) clearance on 2025-04-09, under 510(k) number K242429.

Who is the listed applicant for CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System?

The FDA 510(k) record lists Becton Dickinson Inc. (Bd) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System?

The FDA product code for CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System is SEF.

Related Clinical Trials

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.

NCT01154465A Trial to Study the Influence of Ultrasound Guidance on the Complications of Central CatheterTERMINATEDNCT07291869Central Venous Catheter Placement With Thoracic Ultrasound and Intracavity ECG PositioningRECRUITINGNCT07585188Neonatal Catheter Lock for Infection PreventionNOT_YET_RECRUITINGNCT07697430Medical Adhesive and Barrier Products for Preventing MARSI in Central Venous Catheter DressingsRECRUITINGNCT07175116Advanced Dressings for CVC Infection Prevention in PICUCOMPLETEDNCT07367620Immediate Mechanical Complications After Central Venous CatheterizationCOMPLETED

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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