SHEATHES (NON-LATEX)— 510(k) K963831

Substantially Equivalent

Medical Resources

FDA 510(k) clearance K963831 for SHEATHES (NON-LATEX), Substantially Equivalent on 1997-02-10. Applicant: Medical Resources.

Clearance details

Applicant: Medical Resources
Product code: Code ITX
Advisory panel: Radiology
Date received: 1996-09-24
Decision date: 1997-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

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.