Micro Ace Advanced Micro Access System— 510(k) K232609

Substantially Equivalent

Merit Medical Systems, Inc.

FDA 510(k) clearance K232609 for Micro Ace Advanced Micro Access System, Substantially Equivalent on 2023-09-27. Applicant: Merit Medical Systems, Inc..

Clearance details

Applicant: Merit Medical Systems, Inc.
Product code: Code DRE
Advisory panel: Cardiovascular
Date received: 2023-08-28
Decision date: 2023-09-27
Decision: Substantially Equivalent
Clearance type: Special
Location: South Jordan, UT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRE

product code DRE

Death: 100
Injury: 832
Malfunction: 597
Other: 3
Total: 1,532

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.