PreludeSYNC Radial Compression Device— 510(k) K162988

Substantially Equivalent

Merit Medical Systems, Inc.

FDA 510(k) clearance K162988 for PreludeSYNC Radial Compression Device, Substantially Equivalent on 2017-01-25. Applicant: Merit Medical Systems, Inc..

Clearance details

Applicant: Merit Medical Systems, Inc.
Product code: Code DXC
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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Adverse events under product code DXC

product code DXC

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.