PreludeSYNC Radial Compression Device— 510(k) K262086
Substantially EquivalentMerit Medical Systems, Inc.
FDA 510(k) clearance K262086 for PreludeSYNC Radial Compression Device, Substantially Equivalent on 2026-07-22. Applicant: Merit Medical Systems, Inc.. Device class: 2.
Summary
Merit Medical Systems' PreludeSYNC Radial Compression Device is filed under DXC, vascular clamps. The record doesn't give sizes or describe the device's parts.
Class II, 21 CFR 870.4450. Cardiovascular is both the classification panel and the review panel, and it came in as a Special 510(k).
Merit Medical filed from South Jordan, Utah. Review took 30 calendar days (June 22 to July 22, 2026).
Clearance details
- Applicant
- Merit Medical Systems, Inc.
- Product code
- Product code DXC
- Device class
- Class 2
- Regulation
- 21 CFR 870.4450
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- South Jordan, UT, US
Recent devices under product code DXC
view all- K260105 — Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts
- K252772 — Arc Adjustable Radial Cuff Compression Device
- K254060 — Life Saving Tourniquet
- K243627 — Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)
- K253070 — Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)
More clearances from Merit Medical Systems, Inc.
view allAdverse events under product code DXC
product code DXC- Death
- 14
- Injury
- 442
- Malfunction
- 2,209
- Other
- 1
- Total
- 2,666
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.