FIBERNET EMBOLIC PROTECTION SYSTEM
FDA 510(k) clearance K082348 · decided 2008-11-18
Clearance details
- K-number
- K082348
- Device name
- FIBERNET EMBOLIC PROTECTION SYSTEM
- Applicant
- Lumen Biomedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-08-15
- Decision date
- 2008-11-18
- Days to decision
- 95 days
- Clearance type
- Traditional
- Product code
- NTE
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| FIBERNET Embolic Protection System: Recommended Vessel Diameter 3.5 0 5.0 mm, Maximum Guid recall (Z-1303-2014) | Medtronic Vascular, Inc. | 2014-03-27 |
| FIBERNET Embolic Protection System: Recommended Vessel Diameter 5.0 -6.0 mm, Maximum Guide recall (Z-1304-2014) | Medtronic Vascular, Inc. | 2014-03-27 |