OMF · Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position
General Hospital · 21 CFR 880.5970 · Class 2
Overview
| Product Code | OMF |
|---|---|
| Device Name | Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position |
| Regulation | 21 CFR 880.5970 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| Implant | Yes |
Identification
A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.
Classification Rationale
Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”
Special Controls
*Classification.* Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K093510 | LUMENVU CATHETER GUIDANCE SYSTEM | Sonosite,Inc. | Aug 23, 2010 | SESE |
| K083121 | NEO MAPCATH SENSOR STYLET | Corpak Medsystems | Feb 11, 2009 | SESE |
Top Applicants
- Corpak Medsystems — 1 clearance
- Sonosite,Inc. — 1 clearance
