510(k) K864062— PRUITT EMBOLECTOMY/IRRIGATION CATHETER (MODIFIED)

Substantially Equivalent

Ideas For Medicine, Inc.

Clearance details

Applicant: Ideas For Medicine, Inc.
Product code: Code DXE
Advisory panel: Cardiovascular
Date received: 1986-10-20
Decision date: 1987-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, US

Adverse events under product code DXE

product code DXE

Death: 27
Injury: 258
Malfunction: 2,266
Total: 2,551

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.