PS Medical Ipi Vascular Access Catheter
FDA 510(k) K954409 · Pudenz-Schulte Medical Research Corp.
510(k) numberK954409
Submission
- Device name
- PS Medical Ipi Vascular Access Catheter
- Applicant
- Pudenz-Schulte Medical Research Corp.
Goleta, CA, US - Received
- September 20, 1995
- Decision date
- December 18, 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 |
|---|---|---|
| K960055 | Medtronic PS Medical Bioglide Vascular Catheter, SNGL Lumen Model Nos 8960 & 8932LJS · Traditional | 09/30/1996SE |
| K951258 | PS Medical Bioglide Csf-Flow Control Shunt KitJXG · Traditional | 09/18/1995SE |
| K934796 | Ipi Low Profile ImportLJT · Traditional | 07/14/1994SE |
| K934167 | Ipi Dual Lumen PortLJT · Traditional | 07/14/1994SE |
| K940096 | PS Medical Catheter Placement KitGWG · Traditional | 05/03/1994SE |
| K934545 | PS Medical Delta Burr Hole ValveJXG · Traditional | 04/28/1994SE |
| K930206 | PS Medical Ipi Access KitLJT · Traditional | 02/25/1994SESK |
| K930606 | PS Medical Disposable Subcutaneous Cath PasserGYK · Traditional | 09/10/1993SE |
| K913412 | PS Medical Csf-Access DeviceJXG · Traditional | 03/30/1993SE |
| K922419 | Ipi ImportLJT · Traditional | 11/20/1992SE |
Questions and answers
When was PS Medical Ipi Vascular Access Catheter cleared by the FDA?
PS Medical Ipi Vascular Access Catheter (K954409) received a 510(k) decision of Substantially Equivalent on December 18, 1995, 89 days after the submission was received.
What is the product code of K954409?
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.