Food and Drug Administration
Circulatory System Devices Panel
October 23, 2002
K022071, EMBOL·X Aortic Filter
The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.
Instructions for Use Embol-X Aortic Filter (PDF) (Word)
510(K) Summary of Safety and Effectiveness (PDF) (Word)