FDA-Device2016-12-28Class II
OSCOR ADELANTE BREEZEWAY 10F C120¿ S61CM D66CM Catalog # AB101075 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Oscor, Inc.
Hazard
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Sold states
Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM
Affected count
8
Manufactured in
3816 Desoto Blvd, N/A, Palm Harbor, FL, United States
Products
OSCOR ADELANTE BREEZEWAY 10F C120¿ S61CM D66CM Catalog # AB101075 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0802-2017Don't want to check this manually?
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