WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL (MODI)— 510(k) K914555

Substantially Equivalent

Med Institute, Inc.

FDA 510(k) clearance K914555 for WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL (MODI), Substantially Equivalent on 1992-01-03. Applicant: Med Institute, Inc..

Clearance details

Applicant: Med Institute, Inc.
Product code: Code DRE
Advisory panel: Cardiovascular
Date received: 1991-10-07
Decision date: 1992-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Lafayette, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRE

product code DRE

Death: 100
Injury: 832
Malfunction: 597
Other: 3
Total: 1,532

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.