Steerable Introducer 12F— 510(k) K192422

Substantially Equivalent

Freudenberg Medical, LLC

FDA 510(k) clearance K192422 for Steerable Introducer 12F, Substantially Equivalent on 2019-10-04. Applicant: Freudenberg Medical, LLC.

Clearance details

Applicant: Freudenberg Medical, LLC
Product code: Code DRA
Advisory panel: Cardiovascular
Date received: 2019-09-04
Decision date: 2019-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jeffersonville, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRA

product code DRA

Death: 156
Injury: 3,133
Malfunction: 6,266
Total: 9,555

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.