Cathtong I PICC Catheter
FDA 510(k) K153469 · L&Z Us, Inc.
510(k) numberK153469
Submission
- Device name
- Cathtong I PICC Catheter
- Applicant
- L&Z Us, Inc.
Fort Lee, NJ, US - Received
- December 1, 2015
- Decision date
- September 1, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 |
|---|---|---|
| K233149 | CATHTONG III Tapered PICC CatheterLJS · Special | 12/01/2023SE |
| K232594 | CATHTONG II PICC CatheterLJS · Special | 09/22/2023SE |
| K232571 | CATHTONG II PICC CatheterLJS · Special | 09/22/2023SE |
| K172039 | CATHTONG II PICC CatheterLJS · Special | 08/03/2017SE |
| K170486 | CATHTONG II PICC CatheterLJS · Special | 05/25/2017SE |
Questions and answers
When was Cathtong I PICC Catheter cleared by the FDA?
Cathtong I PICC Catheter (K153469) received a 510(k) decision of Substantially Equivalent on September 1, 2016, 275 days after the submission was received.
What is the product code of K153469?
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.