K100319

Substantially Equivalent

MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R; 503LTCHN-R; 203LTPHN-R,203LTCHWN-R; 503LTCHWN-R; 203L

Applicant: Merit Medical Systems, Inc.
Product code: DTL
Advisory panel: Cardiovascular
Date received: 2010-02-04
Decision date: 2010-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Jordan, UT, US

Adverse events under product code DTL

product code DTL

Malfunction: 770
Total: 770

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.