FDA-Device2016-06-01Class II
Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #: 401450, 401877. Indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.
Stryker Sustainability Solutions
Hazard
Mislabeled for size
Sold states
Distributed in the state of NY and the country of Canada.
Affected count
18 devices
Manufactured in
1810 W Drake Dr, N/A, Tempe, AZ, United States
Products
Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #: 401450, 401877. Indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1708-2016Don't want to check this manually?
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