510(k) K162925
K162925 is an FDA 510(k) premarket notification submitted by Acutus Medical, Inc. for the device "AcQGuide Steerable Sheath". The FDA issued a decision of Substantially Equivalent on April 6, 2017. The device falls under product code DRA (Catheter, Steerable), a Class II device regulated under 21 CFR 870.1280. Acutus Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 6, 2017
- Date Received
- October 19, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Steerable
- Device Class
- Class II
- Regulation Number
- 870.1280
- Review Panel
- CV
- Submission Type