510(k) K200721
K200721 is an FDA 510(k) premarket notification submitted by Abbott (St. Jude Medical) for the device "Agilis HisPro Steerable Catheter With Electrodes". The FDA issued a decision of Substantially Equivalent on June 3, 2020. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Abbott (St. Jude Medical) has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 3, 2020
- Date Received
- March 19, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type