Device product
Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
Z-2070-2021
Product summary
- Event
- Event 88120
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4 units
- Official record key
device-enforcement:Z-2070-2021
Official wording
Reason: Marketed without a 510K
Code information: Lot Numbers: 16F19J0109
Distribution pattern: US Nationwide distribution in the states of FL, ID, IL, NY, OH, TX.
Derived failure modes
-
Unknown
Marketed without a 510K