SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters— 510(k) K162625

Name: FDA 510(k) clearance K162625
Creator: U.S. Food and Drug Administration
Published: 2017-06-12

Substantially Equivalent

B. Braun Interventional Systems, Inc.

FDA 510(k) clearance K162625 for SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters, Substantially Equivalent on 2017-06-12. Applicant: B. Braun Interventional Systems, Inc.. Device class: 2.

Clearance details

Applicant: B. Braun Interventional Systems, Inc.
Product code: Code LOX
Device class: Class 2
Regulation: 21 CFR 870.5100
Advisory panel: Cardiovascular
Date received: 2016-09-20
Decision date: 2017-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, US

Download summary PDF View on FDA.gov ↗

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K252295 — Ryurei2026-03-27

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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.