Catheter Insertion Tray
FDA 510(k) K962849 · Medcare Medical Group, Inc.
510(k) numberK962849
Submission
- Device name
- Catheter Insertion Tray
- Applicant
- Medcare Medical Group, Inc.
East Swanzey, NH, US - Received
- July 22, 1996
- Decision date
- October 7, 1996
- 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 |
|---|---|---|
| K973497 | HuberlocLJT · Traditional | 01/13/1998SE |
| K970152 | Biopsy TrayFRG · Traditional | 03/05/1997SN |
| K961075 | Medcare Regional Anethesia KitCAZ · Traditional | 09/06/1996SEKD |
| K962328 | Single Use Instrument TrayFSM · Traditional | 08/09/1996SE |
| K962527 | General Purpose Dental TrayEIA · Traditional | 08/01/1996SE |
| K961880 | Medcare Suction Connecting TubingGCX · Traditional | 07/19/1996SE |
| K961167 | Medcare Tracheostomy Care TrayLRQ · Traditional | 07/02/1996SESK |
Questions and answers
When was Catheter Insertion Tray cleared by the FDA?
Catheter Insertion Tray (K962849) received a 510(k) decision of Substantially Equivalent on October 7, 1996, 77 days after the submission was received.
What is the product code of K962849?
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.