SHEATHES, STERILE SHEATHES— 510(k) K925869

Name: FDA 510(k) clearance K925869
Creator: U.S. Food and Drug Administration
Published: 1994-01-06

Substantially Equivalent

Mayer Laboratories

FDA 510(k) clearance K925869 for SHEATHES, STERILE SHEATHES, Substantially Equivalent on 1994-01-06. Applicant: Mayer Laboratories. Device class: 2.

Clearance details

Applicant: Mayer Laboratories
Product code: Code ITX
Device class: Class 2
Regulation: 21 CFR 892.1570
Advisory panel: Radiology
Date received: 1992-11-19
Decision date: 1994-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakland, CA, US

Download summary PDF View on FDA.gov ↗

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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.