FDA-Device2016-12-28Class II
OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB10218 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
20
Manufactured in
3816 Desoto Blvd, N/A, Palm Harbor, FL, United States
Products
OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB10218 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-0809-2017Don't want to check this manually?
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