Food and Drug Administration

Circulatory System Devices Panel

October 23, 2002

Briefing Information

K022071, EMBOL·X Aortic Filter

Disclaimer

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)