510(k) K213638
Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003) by
Argon Medical Devices
— Product Code DYB
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 10, 2021
- Date Received
- November 18, 2021
- Clearance Type
- Special
- 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