LUMENVU CATHETER GUIDANCE SYSTEM
FDA 510(k) clearance K093510 · decided 2010-08-23
Clearance details
- K-number
- K093510
- Device name
- LUMENVU CATHETER GUIDANCE SYSTEM
- Applicant
- Sonosite,Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-11-12
- Decision date
- 2010-08-23
- Days to decision
- 284 days
- Clearance type
- Traditional
- Product code
- OMF
- Device class
- 2
- Regulation number
- 880.5970
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Philedelphia, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| NEO MAPCATH SENSOR STYLET (K083121) | Corpak Medsystems | 2009-02-11 |
Recalls involving this device
No recalls on record reference this clearance.