THERATEK GROUP EXCHANGE CATHETER— 510(k) K904680

Substantially Equivalent

Dow Corning Wright

FDA 510(k) clearance K904680 for THERATEK GROUP EXCHANGE CATHETER, Substantially Equivalent on 1990-12-27. Applicant: Dow Corning Wright.

Clearance details

Applicant: Dow Corning Wright
Product code: Code MCW
Advisory panel: Cardiovascular
Date received: 1990-10-15
Decision date: 1990-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami Lakes, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MCW

product code MCW

Death: 38
Injury: 1,386
Malfunction: 2,676
Other: 2
Total: 4,102

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.