PreludeSYNC Radial Compression Device
FDA 510(k) K262086 · Merit Medical Systems, Inc.
510(k) numberK262086
Submission
- Device name
- PreludeSYNC Radial Compression Device
- Applicant
- Merit Medical Systems, Inc.
South Jordan, UT, US - Received
- June 22, 2026
- Decision date
- July 22, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXC – Clamp, Vascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4450
- Specialty
- Cardiovascular
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Questions and answers
When was PreludeSYNC Radial Compression Device cleared by the FDA?
PreludeSYNC Radial Compression Device (K262086) received a 510(k) decision of Substantially Equivalent on July 22, 2026, 30 days after the submission was received.
What is the product code of K262086?
The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.