CORE AND COIL ASSEMBLY GUIDEWIRE— 510(k) K970994

Name: FDA 510(k) clearance K970994
Creator: U.S. Food and Drug Administration
Published: 1997-03-25

Substantially Equivalent

Lake Region Mfg., Inc.

FDA 510(k) clearance K970994 for CORE AND COIL ASSEMBLY GUIDEWIRE, Substantially Equivalent on 1997-03-25. Applicant: Lake Region Mfg., Inc.. Device class: 1.

Clearance details

Applicant: Lake Region Mfg., Inc.
Product code: Code EZB
Device class: Class 1
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1997-03-19
Decision date: 1997-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code EZB

product code EZB

Death: 4
Injury: 141
Malfunction: 588
Total: 733

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.