CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS
FDA 510(k) K153487 · Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
510(k) numberK153487
Submission
- Device name
- CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS
- Applicant
- Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
Reading, PA, US - Received
- December 4, 2015
- Decision date
- February 4, 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 |
|---|---|---|
| K180395 | EZ-IO Intraosseous Vascular Access SystemFMI · Traditional | 11/09/2018SE |
| K163513 | Arrow Endurance Extended Dwell Peripheral Catheter SystemFOZ · Special | 02/24/2017SE |
| K161765 | CG+ Arrow JACCLJS · Special | 09/06/2016SE |
| K161313 | ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and…PND · Traditional | 08/24/2016SE |
| K160018 | Arrow Quickflash Arterial Catheterization DeviceDQX · Traditional | 06/13/2016SE |
| K153423 | CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACCLJS · Special | 01/28/2016SE |
| K152272 | Arrow Endurance Extended Dwell Peripheral Catheter SystemFOZ · Traditional | 11/23/2015SE |
| K143102 | Multi-Lumen Acute Hemodialysis Catheter for High Volume InfusionsNIE · Traditional | 07/24/2015SEKD |
| K123759 | Cg+ Arrow Picc Powered by Arrow VPS StyletLJS · Special | 01/03/2013SE |
Questions and answers
When was CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS cleared by the FDA?
CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS (K153487) received a 510(k) decision of Substantially Equivalent on February 4, 2016, 62 days after the submission was received.
What is the product code of K153487?
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.