510(k) K180723
K180723 is an FDA 510(k) premarket notification submitted by Merit Medical Systems, Inc. for the device "PreludeSYNC DISTAL Radial Compression System". The FDA issued a decision of Substantially Equivalent on Apr 17, 2018. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Merit Medical Systems, Inc. has 180 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 17, 2018
- Date Received
- Mar 19, 2018
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clamp, Vascular
- Device Class
- Class II
- Regulation Number
- 870.4450
- Review Panel
- CV
- Submission Type
- 510(k)