L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Catheters
FDA 510(k) clearance K230669 · decided 2023-11-30
Clearance details
- K-number
- K230669
- Device name
- L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Catheters
- Applicant
- Argon Medical Devices
- Decision
- Substantially Equivalent
- Date received
- 2023-03-10
- Decision date
- 2023-11-30
- Days to decision
- 265 days
- Clearance type
- Traditional
- Product code
- LJS
- Device class
- 2
- Regulation number
- 880.5970
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Athens, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Argon Medical Devices
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x 30cm, REF: 38 recall (Z-2803-2026) | Argon Medical Devices, Inc | 2026-07-24 |
| L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620 recall (Z-2804-2026) | Argon Medical Devices, Inc | 2026-07-24 |
| L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 38 recall (Z-2638-2024) | Argon Medical Devices, Inc | 2024-08-16 |