HYBRID Guidewire— 510(k) K182337

Name: FDA 510(k) clearance K182337
Creator: U.S. Food and Drug Administration
Published: 2018-10-04

Substantially Equivalent

Balt USA, LLC

FDA 510(k) clearance K182337 for HYBRID Guidewire, Substantially Equivalent on 2018-10-04. Applicant: Balt USA, LLC. Device class: 2.

Clearance details

Applicant: Balt USA, LLC
Product code: Code MOF
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 2018-08-28
Decision date: 2018-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MOF

product code MOF

Death: 6
Injury: 137
Total: 143

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.