FDA-Device2018-03-07Class II
Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination¿ Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal, carotid, and peripheral arteries.
Terumo Medical Corporation
Hazard
The tucking depth feature of this catheter introducer is marginally outside the upper specification.
Sold states
To be added.
Affected count
33
Manufactured in
950 Elkton Blvd, N/A, Elkton, MD, United States
Products
Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination¿ Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal, carotid, and peripheral arteries.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0725-2018Don't want to check this manually?
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