BASIXTOUCH— 510(k) K130566

Substantially Equivalent

Merit Medical Systems, Inc.

FDA 510(k) clearance K130566 for BASIXTOUCH, Substantially Equivalent on 2013-06-19. Applicant: Merit Medical Systems, Inc..

Clearance details

Applicant: Merit Medical Systems, Inc.
Product code: Code MAV
Advisory panel: Cardiovascular
Date received: 2013-03-04
Decision date: 2013-06-19
Decision: Substantially Equivalent
Clearance type: Special
Location: South Jordan, UT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MAV

product code MAV

Malfunction: 1,433
Total: 1,433

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.