Footprint Medical Polyurethane Picc Catheter
FDA 510(k) K130507 · Footprint Medical, Inc.
510(k) numberK130507
Submission
- Device name
- Footprint Medical Polyurethane Picc Catheter
- Applicant
- Footprint Medical, Inc.
San Antonio, TX, US - Received
- February 27, 2013
- Decision date
- June 3, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K120304 | Footprint Medical Polyurethane Umbilical CatheterFOS · Special | 03/01/2012SE |
| K102548 | Footprint Medical Polyurethane Feeding TubeKNT · Traditional | 11/26/2010SE |
| K093026 | Footprint Medical 1.9 FR Picc IntroducerDYB · Traditional | 02/24/2010SE |
| K093252 | Footprint Medical Peripherally Inserted Central CatheterLJS · Special | 12/17/2009SE |
| K091214 | Footprint Medical Silicone Umbilical CatheterFOS · Traditional | 09/25/2009SE |
| K091213 | Footprint Medical Umbilical Catheter, Dual LumenFOS · Traditional | 09/25/2009SE |
| K091488 | Footprint Medical Peripherally Inserted Central Catheter, Model S1PIC1.9-CLJS · Traditional | 09/14/2009SE |
| K090576 | Footprint Urinary Drainage CatheterEZD · Traditional | 08/12/2009SE |
| K090559 | Footprint Medical Silicone Feeding TubeKNT · Traditional | 05/04/2009SE |
Questions and answers
When was Footprint Medical Polyurethane Picc Catheter cleared by the FDA?
Footprint Medical Polyurethane Picc Catheter (K130507) received a 510(k) decision of Substantially Equivalent on June 3, 2013, 96 days after the submission was received.
What is the product code of K130507?
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.