Dual-Lumen Long Term Central Venous Cat
FDA 510(k) K834383 · Burron Medical Products, Inc.
510(k) numberK834383
Submission
- Device name
- Dual-Lumen Long Term Central Venous Cat
- Applicant
- Burron Medical Products, Inc.
Walker, MI, US - Received
- December 14, 1983
- Decision date
- May 1, 1984
- 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 |
|---|---|---|
| K870403 | Cavafix(R) Central Venous Catheter Kit W/SutureFOZ · Traditional | 05/01/1987SE |
| K862412 | IntestoplantLLD · Traditional | 11/13/1986SE |
| K861479 | Cavafix, Central Venous Catheter KitFOZ · Traditional | 07/01/1986SESD |
| K860126 | Stimuplex, Nerve StimulatorBXN · Traditional | 02/28/1986SE |
| K851293 | ImplantofixLJT · Traditional | 01/09/1986SE |
| K841428 | Jejunostomy Set for Tube FeedingKNT · Traditional | 07/09/1984SE |
| K834299 | Long Term Central Venous Access CathLJS · Traditional | 05/01/1984SE |
| K834473 | Multi-Lumen Central Venous Cath. KitLJS · Traditional | 04/30/1984SE |
| K840179 | Continuous Epidural Anesthes. TrayCAZ · Traditional | 02/24/1984SE |
| K840287 | Brachial Plexus Anesthesia TrayCAZ · Traditional | 02/23/1984SE |
Questions and answers
When was Dual-Lumen Long Term Central Venous Cat cleared by the FDA?
Dual-Lumen Long Term Central Venous Cat (K834383) received a 510(k) decision of Substantially Equivalent on May 1, 1984, 139 days after the submission was received.
What is the product code of K834383?
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.