FDA-Device2024-05-01Class I
Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
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
10 units
Manufactured in
155 Bovet Rd Ste 100, N/A, San Mateo, CA, United States
Products
Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1610-2024Don't want to check this manually?
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