The following data is part of a premarket notification filed by Sonosite,inc. with the FDA for Lumenvu Catheter Guidance System.
| Device ID | K093510 |
| 510k Number | K093510 |
| Device Name: | LUMENVU CATHETER GUIDANCE SYSTEM |
| Classification | Percutaneous, Implanted, Long-term Intravascular Catheter Accessory For Catheter Position |
| Applicant | SONOSITE,INC. 1835 MARKET ST., 29TH FL. Philadelphia, PA 19103 |
| Contact | Janice Hogan |
| Correspondent | Janice Hogan SONOSITE,INC. 1835 MARKET ST., 29TH FL. Philadelphia, PA 19103 |
| Product Code | OMF |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-12 |
| Decision Date | 2010-08-23 |
| Summary: | summary |