FDA.report

510(k) K242520

Device
Element Vascular Access System
Applicant
Penumbra, Inc.
510(k) number
K242520
Product code
DYB
Decision
Substantially Equivalent (SESE)
Decision date
2024-11-20
Date received
2024-08-23
Regulation
870.1340
Classification name
Introducer, Catheter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Soltanzadeh Sindokht (Sisi)
Address
One Penumbra Pl. Alameda CA US 94502 94502

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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K253741V•Stick™ Vascular Access SetArgon Medical Devices, Inc.2025-12-15
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K251838Introducer Sheath SetCardiocycle Medical(Suzhou) Co., Ltd.2025-10-21