510(k) K212882
K212882 is an FDA 510(k) premarket notification submitted by Merit Medical Systems, Inc. for the device "SCOUT BX Delivery System". The FDA issued a decision of Substantially Equivalent on Apr 8, 2022. The device falls under product code NEU (Marker, Radiographic, Implantable), a Class II device regulated under 21 CFR 878.4300. Merit Medical Systems, Inc. has 180 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 8, 2022
- Date Received
- Sep 10, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Marker, Radiographic, Implantable
- Device Class
- Class II
- Regulation Number
- 878.4300
- Review Panel
- SU
- Submission Type
- 510(k)