FDA-Device2021-07-21Class II
Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr. introducer Product Code: AI-06210-IK - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
Arrow International Inc
Hazard
Marketed without a 510K
Sold states
US Nationwide distribution in the states of FL, ID, IL, NY, OH, TX.
Affected count
5 units
Manufactured in
2400 Bernville Rd, Reading, PA, United States
Products
Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr. introducer Product Code: AI-06210-IK - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2069-2021Don't want to check this manually?
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