FDA-Device2024-05-01Class I
Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
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
750 units
Manufactured in
155 Bovet Rd Ste 100, N/A, San Mateo, CA, United States
Products
Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1611-2024Don't want to check this manually?
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