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FDA 510(k)

Element Vascular Access System

K-Number: K242520 · 2024-11-20

ApplicantPenumbra, Inc.
Decision Date2024-11-20
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Element Vascular Access System is a medical device manufactured by Penumbra, Inc.. It received FDA 510(k) clearance on 2024-11-20 under approval number K242520. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Element Vascular Access System?

Element Vascular Access System is a medical device that received FDA 510(k) clearance on 2024-11-20. It is manufactured by Penumbra, Inc.. The 510(k) number is K242520.

When was Element Vascular Access System approved by the FDA?

Element Vascular Access System received FDA 510(k) clearance on 2024-11-20, under approval number K242520.

What company makes Element Vascular Access System?

Element Vascular Access System is manufactured by Penumbra, Inc..

What is the FDA product code for Element Vascular Access System?

The FDA product code for Element Vascular Access System is DYB.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT07548151 Guided Needle Insertion for Vascular Access COMPLETED NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING NCT06099015 Cera™ Vascular Plug System Post-Market Clinical Follow-Up RECRUITING NCT06472518 Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With Anticoagulation in the Acute Phase of Very Symptomatic Proximal Venous Thrombosis of the Lower Limbs. RECRUITING NCT06904651 VADIOR: Advantages of Pre-operative Positioning of Peripherally Inserted Vascular Accesses in DIVA Patients Undergoing Orthopedic Surgery ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 40258332 Chronic expanding hematoma following Gamma Knife irradiation for primary central nervous system lymphoma: illustrative case. Journal of neurosurgery. Case lessons (2025) PMID: 39977258 Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table. European heart journal (2025)

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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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