FDA-Device2024-05-01Class I
Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices into the neurovasculature and aspiration of thrombus in ischemic stroke patients.
ROUTE 92 MEDICAL INC
Hazard
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Sold states
US: AL AZ CA DE FL GA IA IL IN KY LA MA MD MI MN MO NC ND NJ NY OH OR PA RI SD TN TX UT VA WV OUS: New Zealand
Affected count
19 units
Manufactured in
155 Bovet Rd Ste 100, N/A, San Mateo, CA, United States
Products
Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices into the neurovasculature and aspiration of thrombus in ischemic stroke patients.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1614-2024Don't want to check this manually?
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