Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access set
FDA 510(k) K201489 · Argon Medical Devices, Inc.
510(k) numberK201489
Submission
- Device name
- Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access set
- Applicant
- Argon Medical Devices, Inc.
Athens, TX, US - Received
- June 4, 2020
- Decision date
- December 22, 2020
- 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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| K232679 | Cleaner Pro Thrombectomy System; Cleaner Pro Aspiration Catheter with Handpiece…QEW · Traditional | 01/19/2024SE |
| K233432 | 10F Sheath and Dilator SetDYB · Traditional | 12/08/2023SE |
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Questions and answers
When was Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access set cleared by the FDA?
Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access set (K201489) received a 510(k) decision of Substantially Equivalent on December 22, 2020, 201 days after the submission was received.
What is the product code of K201489?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.