Celerity PICC Tip Confirmation System
FDA 510(k) K142889 · AngioDynamics, Inc.
510(k) numberK142889
Submission
- Device name
- Celerity PICC Tip Confirmation System
- Applicant
- AngioDynamics, Inc.
Marlborough, MA, US - Received
- October 3, 2014
- Decision date
- January 27, 2015
- 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.
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| K252509 | AlphaVac Multipurpose Mechanical Aspiration System F1885QEZ · Traditional | 11/24/2025SE |
| K253106 | AngioVac CannulaDWF · Special | 10/24/2025SE |
| K242687 | NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15…OAB · Traditional | 12/06/2024SE |
| K240397 | AlphaVac MMA F1885 System (H787253020)QEZ · Traditional | 04/01/2024SE |
| K231945 | VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure KitsGEX · Special | 07/20/2023SE |
| K223581 | Solero Microwave Tissue Ablation (MTA) System and AccessoriesNEY · Special | 03/27/2023SE |
| K221883 | Solero Microwave Tissue Ablation (MTA) System and AccessoriesNEY · Special | 03/07/2023SE |
| K213388 | AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 SystemQEZ · Traditional | 04/04/2022SE |
| K213067 | Solero Microwave Tissue Ablation (MTA) System and AccessoriesNEY · Special | 12/03/2021SE |
Questions and answers
When was Celerity PICC Tip Confirmation System cleared by the FDA?
Celerity PICC Tip Confirmation System (K142889) received a 510(k) decision of Substantially Equivalent on January 27, 2015, 116 days after the submission was received.
What is the product code of K142889?
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.