510(k) K212593
K212593 is an FDA 510(k) premarket notification submitted by Biotronick, Inc. for the device "ViaCath, AcQRate Dx Steerable Catheter". The FDA issued a decision of Substantially Equivalent on October 15, 2021. The device falls under product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording), a Class II device regulated under 21 CFR 870.1220.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 15, 2021
- Date Received
- August 16, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Electrode Recording, Or Probe, Electrode Recording
- Device Class
- Class II
- Regulation Number
- 870.1220
- Review Panel
- CV
- Submission Type