Vascular Access Catheter Accessories
FDA 510(k) K935380 · Bard Access Systems, Inc.
510(k) numberK935380
Submission
- Device name
- Vascular Access Catheter Accessories
- Applicant
- Bard Access Systems, Inc.
Salt Lake City, UT, US - Received
- November 8, 1993
- Decision date
- February 17, 1995
- 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 |
|---|---|---|
| K252478 | Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable…LJT · Special | 09/05/2025SE |
| K251253 | PowerPort isp Implantable Port; PowerPort Slim Implantable Port; PowerPort M.R.I. …LJT · Special | 06/18/2025SE |
| K241353 | PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle SetPTI · Traditional | 11/27/2024SE |
| K242328 | PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable…LJT · Special | 10/31/2024SE |
| K240146 | BD Prevue II Peripheral Vascular Access SystemIYO · Special | 02/18/2024SE |
| K223198 | BD Intraosseous Vascular Access System EMS Powered Driver (D001003)MHC · Special | 11/10/2022SE |
| K222232 | Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock AssemblyLJS · Special | 08/24/2022SE |
| K210264 | BD PowerPiCC CatheterLJS · Traditional | 07/30/2021SE |
| K120882 | Site Rite Prevue Ultrasound System and Pinpoint Needle GuideIYO · Traditional | 05/30/2012SE |
| K100402 | Site-Rite Vision Ultrasound SystemIYN · Traditional | 03/05/2010SE |
Questions and answers
When was Vascular Access Catheter Accessories cleared by the FDA?
Vascular Access Catheter Accessories (K935380) received a 510(k) decision of Substantially Equivalent on February 17, 1995, 466 days after the submission was received.
What is the product code of K935380?
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.