Medcomp Bio-Cath Catheter Line
FDA 510(k) K003110 · Medcomp
510(k) numberK003110
Submission
- Device name
- Medcomp Bio-Cath Catheter Line
- Applicant
- Medcomp
Harleysville, PA, US - Received
- October 4, 2000
- Decision date
- December 1, 2000
- 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 |
|---|---|---|
| K130889 | Split Cath RGMSD · Traditional | 04/28/2014SESK |
| K123292 | T3NIE · Traditional | 06/11/2013SE |
| K102966 | 2.6F X 20CM Vascu-Picc, 2.6F X 50CM Vascu-PiccLJS · Traditional | 12/21/2010SE |
| K091954 | Micro-Stick SetDYB · Traditional | 01/08/2010SE |
| K092347 | Pro-Picc CTLJS · Special | 09/16/2009SE |
| K091953 | Pro-PiccLJS · Traditional | 09/16/2009SE |
| K090394 | Valved Tearway IntroducerDYB · Traditional | 09/01/2009SE |
| K091586 | Vascu-Picc and Midline Catheters, Single, Double and Triple LumenLJS · Traditional | 07/23/2009SE |
| K091466 | 1.9F X 20CM Vascu-Picc, 1.9F X 50CM Vascu-Picc, Model VPI.9S20, VPI.9S50LJS · Special | 06/17/2009SE |
| K081775 | The Medcomp .010 Vascular GuidewiresDQX · Traditional | 03/25/2009SE |
Questions and answers
When was Medcomp Bio-Cath Catheter Line cleared by the FDA?
Medcomp Bio-Cath Catheter Line (K003110) received a 510(k) decision of Substantially Equivalent on December 1, 2000, 58 days after the submission was received.
What is the product code of K003110?
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.