510(k) K093510
K093510 is an FDA 510(k) premarket notification submitted by Sonosite,Inc. for the device "LUMENVU CATHETER GUIDANCE SYSTEM". The FDA issued a decision of Substantially Equivalent on August 23, 2010. The device falls under product code OMF (Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position), a Class II device regulated under 21 CFR 880.5970. Sonosite,Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 23, 2010
- Date Received
- November 12, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position
- Device Class
- Class II
- Regulation Number
- 880.5970
- Review Panel
- HO
- Submission Type
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.