Dual Lumen Catheter for Chronic Vascular Access
FDA 510(k) K892926 · Vas-Cath, Inc.
510(k) numberK892926
Submission
- Device name
- Dual Lumen Catheter for Chronic Vascular Access
- Applicant
- Vas-Cath, Inc.
Mississauga,Ontario, CA - Received
- April 21, 1989
- Decision date
- December 5, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K973013 | Opti-Plast (Centurion) 5.5F Angioplasty CatheterLIT · Traditional | 06/19/1998SE |
| K965178 | Niagara Dual Lumen CatheterMPB · Traditional | 08/19/1997SE |
| K964881 | Ultraverse Pta CatheterLIT · Traditional | 05/28/1997SE |
| K970725 | Opti-Plast XL 5.5 F Pta CatheterLIT · Traditional | 05/09/1997SE |
| K941706 | Opti-Plast Angioplasty CatheterLIT · Traditional | 10/18/1994SE |
| K925485 | Vas-Cath Inc. Opti-Plast Angioplasty CatheterLIT · Traditional | 03/10/1994SE |
| K933483 | Opti-Plast 5F Pta CathetersLIT · Traditional | 09/24/1993SE |
| K914210 | Vas-Cath Dualator(Tm) Vessel DilatorFKA · Traditional | 07/01/1993SE |
| K914162 | Vas-Cath Flexxicon 2 Dual Lumen Dialysis CathetersLFJ · Traditional | 07/01/1993SE |
| K914976 | Opti-Plast 5F Pta Catheters, ModificationLIT · Traditional | 01/27/1992SE |
Questions and answers
When was Dual Lumen Catheter for Chronic Vascular Access cleared by the FDA?
Dual Lumen Catheter for Chronic Vascular Access (K892926) received a 510(k) decision of Substantially Equivalent on December 5, 1989, 228 days after the submission was received.
What is the product code of K892926?
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.