FDA-Device2024-05-01Class I
Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. 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
200 units
Manufactured in
155 Bovet Rd Ste 100, N/A, San Mateo, CA, United States
Products
Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1613-2024Don't want to check this manually?
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