MERIT MAK (MINI ACCESS KIT) WITH PALLADIUM TIP GUIDE WIRE— 510(k) K091584

Substantially Equivalent

Merit Medical Systems, Inc.

FDA 510(k) clearance K091584 for MERIT MAK (MINI ACCESS KIT) WITH PALLADIUM TIP GUIDE WIRE, Substantially Equivalent on 2009-10-09. Applicant: Merit Medical Systems, Inc..

Clearance details

Applicant: Merit Medical Systems, Inc.
Product code: Code DRE
Advisory panel: Cardiovascular
Date received: 2009-06-02
Decision date: 2009-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
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.