FDA-Device2021-07-21Class II
Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr. introducer Product Code: AI-07155-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
15 units
Manufactured in
2400 Bernville Rd, Reading, PA, United States
Products
Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr. introducer Product Code: AI-07155-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-2071-2021Don't want to check this manually?
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