PreludeSYNC Radial Compression Device— 510(k) K162988

Clearance details

Applicant

Merit Medical Systems, Inc.

Product code

Code DXC

Device class

Class 2

Regulation

21 CFR 870.4450

Advisory panel

Cardiovascular

Date received

2016-10-27

Decision date

2017-01-25

Decision

Substantially Equivalent

Clearance type

Traditional

Location

South Jordan, UT, US

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Death

14

Injury

442

Malfunction

2,209

Other

1

Total

2,666

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1766-2017 — The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis of the radial and ulnar artery following catheterization procedures. It has a soft wristband with a secure hook and loop fastener. The band delivers adjustable compression of the puncture site with an inflatable bulb, and a check valve for easy inflation and deflation with a syringe. A clear curved backer plate provides optimal visualization of the puncture site and ease of placement.Class II·Terminated·Merit Medical Systems, Inc.·20170303

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162988.