Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set— 510(k) K202141
Substantially EquivalentArgon Medical Devices, Inc.
FDA 510(k) clearance K202141 for Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set, Substantially Equivalent on 2021-01-15. Applicant: Argon Medical Devices, Inc.. Device class: 2.
Clearance details
- Applicant
- Argon Medical Devices, Inc.
- 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
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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 →
Recalls naming K202141
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K202141.
Data sourced from openFDA. This site is unofficial and independent of the FDA.