Device product
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.
Z-2071-2021
Product summary
- Event
- Event 88120
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 15 units
- Official record key
device-enforcement:Z-2071-2021
Official wording
Reason: Marketed without a 510K
Code information: Lot Numbers: 23F20A0230 23F20E0004 23F20E0094
Distribution pattern: US Nationwide distribution in the states of FL, ID, IL, NY, OH, TX.
Derived failure modes
-
Unknown
Marketed without a 510K