Uni-Picc
FDA 510(k) K130034 · Health Line International Corporation
510(k) numberK130034
Submission
- Device name
- Uni-Picc
- Applicant
- Health Line International Corporation
Centerville, UT, US - Received
- January 7, 2013
- Decision date
- March 8, 2013
- 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 |
| 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 |
|---|---|---|
| K261950 | Health Line Tearaway IntroducerDYB · Traditional | 06/22/2026SE |
| K222170 | Power Acute Triple Lumen Hemodialysis CatheterNIE · Traditional | 01/13/2023SE |
| K200426 | Acute Dual Lumen Hemodialysis CatheterMPB · Traditional | 12/24/2020SESK |
| K200263 | Health Line CT Midline CatheterFOZ · Special | 03/12/2020SE |
| K192533 | Health Line CT CVCFOZ · Traditional | 12/10/2019SE |
| K160448 | ArtlineDQY · Traditional | 07/12/2016SE |
| K140270 | Nexus Midline CT CatheterFOZ · Traditional | 08/20/2014SE |
| K130851 | Cascade Hemodialysis/Apheresis CatheterMSD · Traditional | 01/09/2014SESK |
| K120548 | Hlic Needle-Less ValveFPA · Traditional | 05/04/2012SE |
| K101329 | Synergy CT PiccLJS · Traditional | 08/19/2010SE |
Questions and answers
When was Uni-Picc cleared by the FDA?
Uni-Picc (K130034) received a 510(k) decision of Substantially Equivalent on March 8, 2013, 60 days after the submission was received.
What is the product code of K130034?
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.