Lumen Biomedical, Inc.
FDA Regulatory Profile
Lumen Biomedical, Inc. appears in FDA public data with 0 recalls, 5 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on August 17, 2011.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 5
- Inspections
- 2
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K111987 | FIBERNET EMBOLIC PROTECTION DEVICE | August 17, 2011 |
| K082348 | FIBERNET EMBOLIC PROTECTION SYSTEM | November 18, 2008 |
| K080901 | LBI EMBOLECTOMY SYSTEM | October 2, 2008 |
| K071529 | XTRACT CATHETER SYSTEM | August 10, 2007 |
| K053372 | LBI CATHETER SYSTEM | June 30, 2006 |