Onecath L-Cath Catheter System
FDA 510(k) K930473 · Luther Medical Products, Inc.
510(k) numberK930473
Submission
- Device name
- Onecath L-Cath Catheter System
- Applicant
- Luther Medical Products, Inc.
Tustin, CA, US - Received
- January 28, 1993
- Decision date
- April 7, 1994
- Decision
- Unknown (SEKD)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LJS – Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5970
- Specialty
- General Hospital
- Implant
- Yes
Other 510(k)s with product code LJS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260929 | Neonav ECG Tip Location SystemLJS · Special | Navi Medical Technologies | 04/17/2026SE |
| K252373 | BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with…LJS · Traditional | Spectrum Vascular | 12/16/2025SE |
| K252792 | PM2 System with ECGuide ConnectorLJS · Special | Piccolo Medical, Inc. | 11/17/2025SE |
| K243458 | HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301)…LJS · Traditional | Access Vascular, Inc. | 08/01/2025SE |
| K251212 | Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC…LJS · Special | Access Vascular, Inc. | 07/01/2025SE |
| K243484 | PM2+ System and SmartPICC StyletLJS · Traditional | Piccolo Medical, Inc. | 05/29/2025SE |
| K241587 | pilot TLSLJS · Traditional | Vygon Corporation | 02/26/2025SE |
| K241910 | Neonav ECG Tip Location SystemLJS · Traditional | Navi Medical Technologies | 01/19/2025SE |
| K243941 | HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201)…LJS · Special | Access Vascular, Inc. | 01/17/2025SE |
| K240486 | PM2 System and ECGuide ConnectorLJS · Traditional | Piccolo Medical, Inc. | 09/08/2024SE |
More from Piccolo Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K982797 | Blunt T-Peel Introducer Model Number PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICBDYB · Traditional | 11/30/1998SE |
| K980090 | Onecath, L-Cath Catheter System, Model OC-(16-22 Ga., 5CM-60CM)LJS · Traditional | 03/24/1998SE |
| K974543 | L-Cath Modified Seldinger Technique Insertion/Catheter Exchange Kit PE-MST24-24 Ga. Kit…FOZ · Traditional | 02/10/1998SE |
| K940198 | L-Cath Connector AssemblyGCD · Traditional | 12/15/1994SE |
| K942103 | L-Cath Catheter System - Port L-CathLJT · Traditional | 07/26/1994SE |
| K925236 | L Cath(R) Catheter SystemLJS · Traditional | 03/22/1994SE |
| K920755 | L-Cath Peel Away System CatheterLJS · Traditional | 06/07/1993SE |
| K925979 | Dual Lumen L-Cath Catheter SystemDQX · Traditional | 05/27/1993SE |
| K924968 | L-Cath Peel-Away Catheter SystemFOZ · Traditional | 05/21/1993SE |
| K924562 | Catheter IntroducerDYB · Traditional | 02/25/1993SE |
Questions and answers
When was Onecath L-Cath Catheter System cleared by the FDA?
Onecath L-Cath Catheter System (K930473) received a 510(k) decision of Unknown on April 7, 1994, 434 days after the submission was received.
What is the product code of K930473?
The FDA product code is LJS – Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, a Class II (moderate risk) device regulated under 21 CFR 880.5970.