NC Quantum Apex PTCA Dilatation Catheter— 510(k) K160823

Name: FDA 510(k) clearance K160823
Creator: U.S. Food and Drug Administration
Published: 2016-06-23

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K160823 for NC Quantum Apex PTCA Dilatation Catheter, Substantially Equivalent on 2016-06-23. Applicant: Boston Scientific Corporation. Device class: 2.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code LOX
Device class: Class 2
Regulation: 21 CFR 870.5100
Advisory panel: Cardiovascular
Date received: 2016-03-25
Decision date: 2016-06-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Maple Grove, MN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LOX

product code LOX

Death: 190
Injury: 1,498
Malfunction: 9,670
Total: 11,358

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.