MENTOR DUCTAL CATHETERS— 510(k) K895285

Name: FDA 510(k) clearance K895285
Creator: U.S. Food and Drug Administration
Published: 1989-10-17

Substantially Equivalent

Mentor Corp.

FDA 510(k) clearance K895285 for MENTOR DUCTAL CATHETERS, Substantially Equivalent on 1989-10-17. Applicant: Mentor Corp.. Device class: 1.

Clearance details

Applicant: Mentor Corp.
Product code: Code GBZ
Device class: Class 1
Regulation: 21 CFR 878.4200
Advisory panel: General, Plastic Surgery
Date received: 1989-08-24
Decision date: 1989-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goleta, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GBZ

product code GBZ

Death: 2
Total: 2

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.