DK-PTCA BALLOON CATHETER— 510(k) K123264

Name: FDA 510(k) clearance K123264
Creator: U.S. Food and Drug Administration
Published: 2013-01-16

Substantially Equivalent

Intuit Medical, LLC

FDA 510(k) clearance K123264 for DK-PTCA BALLOON CATHETER, Substantially Equivalent on 2013-01-16. Applicant: Intuit Medical, LLC. Device class: 2.

Clearance details

Applicant: Intuit Medical, LLC
Product code: Code LOX
Device class: Class 2
Regulation: 21 CFR 870.5100
Advisory panel: Cardiovascular
Date received: 2012-10-18
Decision date: 2013-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sugar Hill, GA, 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.