Triple Lumen PFM Picc
FDA 510(k) K110914 · Pfm Medical, Inc.
510(k) numberK110914
Submission
- Device name
- Triple Lumen PFM Picc
- Applicant
- Pfm Medical, Inc.
Carlsbad, CA, US - Received
- April 1, 2011
- Decision date
- September 21, 2011
- 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 |
|---|---|---|
| K242763 | JetCan® Pro Safety Huber NeedleFPA · Traditional | 05/02/2025SE |
| K241278 | ASEPT® Glide Peritoneal Drainage SystemPNG · Traditional | 01/14/2025SE |
| K221779 | ASEPT Peritoneal Drainage SystemPNG · Traditional | 05/02/2023SESK |
| K213666 | NuCath Wedge Pressure CatheterDQO · Traditional | 10/06/2022SE |
| K201137 | Asept Surgical Face MaskFXX · Abbreviated | 08/19/2020SE |
| K192802 | primeMidline CathetersPND · Special | 10/28/2019SE |
| K173114 | primeMidline CathetersPND · Traditional | 03/07/2018SE |
| K140137 | Safety Biopsy Needle SystemFCG · Traditional | 03/25/2014SE |
| K122402 | LPP (Low Profile Port)LJT · Traditional | 07/16/2013SE |
| K113354 | Veta Peritoneal Dialysis CatheterFJS · Traditional | 03/13/2012SESK |
Questions and answers
When was Triple Lumen PFM Picc cleared by the FDA?
Triple Lumen PFM Picc (K110914) received a 510(k) decision of Substantially Equivalent on September 21, 2011, 173 days after the submission was received.
What is the product code of K110914?
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.