MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE— 510(k) K083523

Substantially Equivalent

Merit Medical Systems, Inc.

FDA 510(k) clearance K083523 for MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE, Substantially Equivalent on 2009-02-04. Applicant: Merit Medical Systems, Inc..

Clearance details

Applicant: Merit Medical Systems, Inc.
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 2008-11-26
Decision date: 2009-02-04
Decision: Substantially Equivalent
Clearance type: Special
Location: South Jordan, UT, US

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Adverse events under product code DXT

product code DXT

Death: 39
Injury: 242
Malfunction: 463
Other: 3
Total: 747

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.