FDA-Device2023-05-17Class I
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM
Cordis US Corp
Hazard
There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared.
Sold states
Worldwide distribution.
Affected count
N/A
Manufactured in
14201 Nw 60th Ave, N/A, Miami Lakes, FL, United States
Products
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1495-2023Don't want to check this manually?
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