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FDA 510(k)

SCORPION Portal Vein Access Set

K-Number: K213002 · 2021-10-14

ApplicantArgon Medical Devices
Decision Date2021-10-14
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SCORPION Portal Vein Access Set is a medical device manufactured by Argon Medical Devices. It received FDA 510(k) clearance on 2021-10-14 under approval number K213002. 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 SCORPION Portal Vein Access Set?

SCORPION Portal Vein Access Set is a medical device that received FDA 510(k) clearance on 2021-10-14. It is manufactured by Argon Medical Devices. The 510(k) number is K213002.

When was SCORPION Portal Vein Access Set approved by the FDA?

SCORPION Portal Vein Access Set received FDA 510(k) clearance on 2021-10-14, under approval number K213002.

What company makes SCORPION Portal Vein Access Set?

SCORPION Portal Vein Access Set is manufactured by Argon Medical Devices.

What is the FDA product code for SCORPION Portal Vein Access Set?

The FDA product code for SCORPION Portal Vein Access Set is DYB.

Other Devices by Argon Medical Devices

K213638Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003) K213232NovaCore Semi-Automatic Biopsy Instrument K230669L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Catheters K230631Kodiak™ Dual Port Coaxial Introducer Kit

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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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