510(k) K093510
- Device
- LUMENVU CATHETER GUIDANCE SYSTEM
- Applicant
- SONOSITE,INC.
- 510(k) number
- K093510
- Product code
- OMF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-08-23
- Date received
- 2009-11-12
- Regulation
- 880.5970
- Classification name
- Percutaneous, Implanted, Long-term Intravascular Catheter Accessory For Catheter Position
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JANICE HOGAN
- Address
- 1835 Market St., 29th Floor Philedelphia PA US 19103 19103
Source Documents#
Other 510(k) Records For Product Code OMF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K083121 | NEO MAPCATH SENSOR STYLET | Corpak Medsystems | 2009-02-11 |
Legacy Summary#
summary
FDA Review#
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