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

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..

Clearance details

Applicant: B. Braun Interventional Systems, Inc.
Product code: Code LOX
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 ↗

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.