Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set
FDA 510(k) K202141 · Argon Medical Devices, Inc.
510(k) numberK202141
Submission
- Device name
- Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set
- Applicant
- Argon Medical Devices, Inc.
Athens, TX, US - Received
- July 31, 2020
- Decision date
- January 15, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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| K233432 | 10F Sheath and Dilator SetDYB · Traditional | 12/08/2023SE |
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Questions and answers
When was Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set cleared by the FDA?
Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set (K202141) received a 510(k) decision of Substantially Equivalent on January 15, 2021, 168 days after the submission was received.
What is the product code of K202141?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.