510(k) K201489
Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access set by
Argon Medical Devices, Inc.
— Product Code DYB
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 2020
- Date Received
- June 4, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Introducer, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1340
- Review Panel
- CV
- Submission Type