SCORPION Portal Vein Access Set— 510(k) K213002
Substantially EquivalentArgon Medical Devices
FDA 510(k) clearance K213002 for SCORPION Portal Vein Access Set, Substantially Equivalent on 2021-10-14. Applicant: Argon Medical Devices. Device class: 2.
Clearance details
- Applicant
- Argon Medical Devices
- Product code
- Code DYB
- Device class
- Class 2
- Regulation
- 21 CFR 870.1340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Athens, TX, US
Recent devices under product code DYB
view allMore clearances from Argon Medical Devices
view all- K230669 — L-Cath Single and Dual Lumen Catheters, L-Cath Midline Catheters
- K230631 — Kodiak Dual Port Coaxial Introducer Kit
- K213232 — NovaCore Semi-Automatic Biopsy Instrument
- 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)
Adverse events under product code DYB
product code DYB- Death
- 808
- Injury
- 5,922
- Malfunction
- 16,516
- Other
- 5
- Total
- 23,251
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.