MMS PTA Balloon Catheter— 510(k) K152934

Substantially Equivalent

Micro Medical Solutions, Inc.

FDA 510(k) clearance K152934 for MMS PTA Balloon Catheter, Substantially Equivalent on 2016-04-25. Applicant: Micro Medical Solutions, Inc..

Clearance details

Applicant: Micro Medical Solutions, Inc.
Product code: Code LIT
Advisory panel: Cardiovascular
Date received: 2015-10-05
Decision date: 2016-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Quincy, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LIT

product code LIT

Death: 27
Injury: 1,256
Malfunction: 12,127
Total: 13,410

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.