MERIT MAK (MINI ACCESS KIT)— 510(k) K031691

Substantially Equivalent

Merit Medical Systems, Inc.

FDA 510(k) clearance K031691 for MERIT MAK (MINI ACCESS KIT), Substantially Equivalent on 2003-09-03. Applicant: Merit Medical Systems, Inc..

Clearance details

Applicant: Merit Medical Systems, Inc.
Product code: Code DRE
Advisory panel: Cardiovascular
Date received: 2003-06-02
Decision date: 2003-09-03
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: South Jordan, UT, US

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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.