pilot TLS
FDA 510(k) K241587 · Vygon Corporation
510(k) numberK241587
Submission
- Device name
- pilot TLS
- Applicant
- Vygon Corporation
Lansdale Montgomery, PA, US - Received
- June 3, 2024
- Decision date
- February 26, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| 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 |
| K233149 | CATHTONG III Tapered PICC CatheterLJS · Special | L&Z Us, Inc. | 12/01/2023SE |
More from L&Z Us, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K151237 | Nutrisafe 2- ENFit AdaptorPIO · Traditional | 02/09/2016SE |
| K141026 | LeaderflexFOZ · Traditional | 07/30/2014SE |
| K121105 | Nutrisafe 2 Feeding TubeFPD · Traditional | 12/18/2012SE |
| K100163 | Nutrisafe 2 Feeding Tubes Model 362.XXX. 1362.XXXFPD · Traditional | 10/13/2011SE |
| K073493 | Hepatostat SetGAM · Traditional | 05/06/2008SE |
| K070705 | Modification to: Latex-Free Bionector, Model# 896.019, 896.039FOZ · Traditional | 11/30/2007SE |
| K061796 | Hepatostat Set, Model 760XGAM · Traditional | 11/02/2006SE |
| K061250 | Multicath ExpertFOZ · Traditional | 09/29/2006SE |
| K062425 | Lifecath S Picc and Midline CatheterLJS · Special | 09/15/2006SE |
| K060944 | Nutrisafe 2FPD · Special | 09/15/2006SE |
Questions and answers
When was pilot TLS cleared by the FDA?
pilot TLS (K241587) received a 510(k) decision of Substantially Equivalent on February 26, 2025, 268 days after the submission was received.
What is the product code of K241587?
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.