L-Cath Single and Dual Lumen Catheters, L-Cath Midline Catheters— 510(k) K230669
Substantially EquivalentArgon Medical Devices
FDA 510(k) clearance K230669 for L-Cath Single and Dual Lumen Catheters, L-Cath Midline Catheters, Substantially Equivalent on 2023-11-30. Applicant: Argon Medical Devices. Device class: 2.
Clearance details
- Applicant
- Argon Medical Devices
- Product code
- Code LJS
- Device class
- Class 2
- Regulation
- 21 CFR 880.5970
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Athens, TX, US
Recent devices under product code LJS
view all- K260929 — Neonav ECG Tip Location System
- K252373 — BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology +6 more
- K252792 — PM2 System with ECGuide Connector
- K243458 — HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301) +5 more
- K251212 — Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)
More clearances from Argon Medical Devices
view all- 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)
- K213002 — SCORPION Portal Vein Access Set
Adverse events under product code LJS
product code LJS- Death
- 31
- Injury
- 2,791
- Malfunction
- 18,374
- Other
- 5
- Total
- 21,201
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 K230669
K-number listed on FDA's recall record- Z-2803-2026 — L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x 30cm, REF: 384539; 18ga (3.5F) 1.15mm x 60cm, REF: 384464; Basic Kit 28GA (1.2F) x 25cm 1 Lumen), REF: 384516; 20ga (3F) 1.00mm x 60cm, REF: 384463
- Z-2804-2026 — L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620
- Z-2638-2024 — L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K230669.
Data sourced from openFDA. This site is unofficial and independent of the FDA.