FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003)
K Number: K213638
·
Decision Dec 10, 2021
Classifications
1
FEI Numbers
273
Registration Numbers
273
Same Product Code
701
Applicant Total
5
Review Days
22
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Basic Information
- Device Name
- Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003)
- K Number
- K213638
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Argon Medical Devices
- Date Received
- November 18, 2021
- Decision Date
- December 10, 2021
- Product Code
- DYB
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DYB | Introducer, Catheter | FDA class 2 | Cardiovascular |
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Other Clearances by Argon Medical Devices
| K Number | Device Name | ||
|---|---|---|---|
| K230669 | L-Cath Single and Dual Lumen Catheters, L-Cath Midline Catheters | Nov 30, 2023 | Substantially Equivalent |
| K230631 | Kodiak Dual Port Coaxial Introducer Kit | May 22, 2023 | Substantially Equivalent |
| K213232 | NovaCore Semi-Automatic Biopsy Instrument | Jul 1, 2022 | Substantially Equivalent |
| K213002 | SCORPION Portal Vein Access Set | Oct 14, 2021 | Substantially Equivalent |