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Lumen Biomedical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K111987FIBERNET EMBOLIC PROTECTION DEVICEAugust 17, 2011
K082348FIBERNET EMBOLIC PROTECTION SYSTEMNovember 18, 2008
K080901LBI EMBOLECTOMY SYSTEMOctober 2, 2008
K071529XTRACT CATHETER SYSTEMAugust 10, 2007
K053372LBI CATHETER SYSTEMJune 30, 2006