Lumenvu Catheter Guidance System
FDA 510(k) K093510 · Sonosite,Inc.
510(k) numberK093510
Submission
- Device name
- Lumenvu Catheter Guidance System
- Applicant
- Sonosite,Inc.
Philedelphia, PA, US - Received
- November 12, 2009
- Decision date
- August 23, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OMF – Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5970
- Specialty
- General Hospital
- Implant
- Yes
When used in connection with a locator instrument is designed to aid in the placement of central venous catheters by providing real-time information as to the position of the catheter inside the body during the catheter insertion procedure.
Other 510(k)s with product code OMF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K083121 | Neo Mapcath Sensor StyletOMF · Traditional | Corpak Medsystems | 02/11/2009SE |
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Questions and answers
When was Lumenvu Catheter Guidance System cleared by the FDA?
Lumenvu Catheter Guidance System (K093510) received a 510(k) decision of Substantially Equivalent on August 23, 2010, 284 days after the submission was received.
What is the product code of K093510?
The FDA product code is OMF – Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position, a Class II (moderate risk) device regulated under 21 CFR 880.5970.