FDA-Device2013-02-27Class II
NEUROPATH 6Fx100 GUIDING CATH ST Product Code: GST61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Codman & Shurtleff, Inc.
Hazard
Sterility of device may be compromised due to lack of package integrity
Sold states
Worldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland.
Affected count
266 units
Manufactured in
325 Paramount Drive, N/A, Raynham, MA, United States
Products
NEUROPATH 6Fx100 GUIDING CATH ST Product Code: GST61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0849-2013Don't want to check this manually?
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