510(k) K950201— ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER

Substantially Equivalent

Sherwood Medical Co.

Clearance details

Applicant: Sherwood Medical Co.
Product code: Code JOL
Advisory panel: General Hospital
Date received: 1995-01-18
Decision date: 1995-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Adverse events under product code JOL

product code JOL

Death: 7
Injury: 177
Malfunction: 1,306
Other: 1
Total: 1,491

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.