510(k) K171557
K171557 is an FDA 510(k) premarket notification submitted by Acutus Medical, Inc. for the device "AcQRef Introducer Sheath". The FDA issued a decision of Substantially Equivalent on Feb 6, 2018. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Acutus Medical, Inc. has 23 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 6, 2018
- Date Received
- May 30, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Introducer, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1340
- Review Panel
- CV
- Submission Type
- 510(k)