Kodiak Dual Port Coaxial Introducer Kit— 510(k) K230631
Substantially EquivalentArgon Medical Devices
FDA 510(k) clearance K230631 for Kodiak Dual Port Coaxial Introducer Kit, Substantially Equivalent on 2023-05-22. 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
- Traditional
- 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
- 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)
- K213002 — SCORPION Portal Vein Access Set
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.