Non-Sterile Broviac Parenteral Alimi-
FDA 510(k) K830256 · Evermed, Inc.
510(k) numberK830256
Submission
- Device name
- Non-Sterile Broviac Parenteral Alimi-
- Applicant
- Evermed, Inc.
Walker, MI, US - Received
- January 25, 1983
- Decision date
- March 1, 1983
- 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 |
|---|---|---|
| K023993 | Galaxy Series WheelchairIOR · Traditional | 12/27/2002SE |
| K024030 | Millennium Series Manual WheelchairsIOR · Traditional | 12/12/2002SE |
| K023485 | Explorer Powered WheelchairITI · Traditional | 12/02/2002SE |
| K840846 | Sterile Hichman/Broviac Injection CapLJS · Traditional | 07/06/1984SE |
| K840529 | Steiger Tunneling Instrument 285DRC · Traditional | 03/12/1984SE |
| K830406 | Non-Sterile Catheter Repair KitsLJS · Traditional | 03/01/1983SE |
| K830233 | Non-Sterile,Single/Souble Lumen-CathLJS · Traditional | 02/28/1983SE |
| K830257 | Non-Sterile Peritoneal Access Cathet-FKX · Traditional | 02/24/1983SE |
Questions and answers
When was Non-Sterile Broviac Parenteral Alimi- cleared by the FDA?
Non-Sterile Broviac Parenteral Alimi- (K830256) received a 510(k) decision of Substantially Equivalent on March 1, 1983, 35 days after the submission was received.
What is the product code of K830256?
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.