FDA-Device2021-07-21Class II
Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - 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
48 units
Manufactured in
2400 Bernville Rd, Reading, PA, United States
Products
Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - 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-2068-2021Don't want to check this manually?
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