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FDA 510(k)

SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters

K-Number: K162625 · 2017-06-12

ApplicantB. Braun Interventional Systems, Inc.
Decision Date2017-06-12
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters is a medical device manufactured by B. Braun Interventional Systems, Inc.. It received FDA 510(k) clearance on 2017-06-12 under approval number K162625. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters?

SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters is a medical device that received FDA 510(k) clearance on 2017-06-12. It is manufactured by B. Braun Interventional Systems, Inc.. The 510(k) number is K162625.

When was SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters approved by the FDA?

SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters received FDA 510(k) clearance on 2017-06-12, under approval number K162625.

What company makes SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters?

SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters is manufactured by B. Braun Interventional Systems, Inc..

What is the FDA product code for SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters?

The FDA product code for SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters is LOX.

Related Clinical Trials

NCT07296744 Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI) RECRUITING NCT06353594 Reduced Stent Strategy Versus Conventional Percutaneous Coronary Revascularization in Patients Presenting With STEMI RECRUITING NCT05846893 Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease ACTIVE_NOT_RECRUITING NCT05493904 PREcise Percutaneous Coronary Intervention for Stent OptimizatION in Treatment of COMPLEX Lesion (PRECISION-COMPLEX) ACTIVE_NOT_RECRUITING NCT05147363 Shockwave: Disruption for A Better Fit WITHDRAWN NCT07190690 Comparison of a Contemporary Sirolimus-eluting Stent (ihtDEStiny®) With Another Everolimus-eluting Stent (Xience™), Both With Permanent Polymers, in Patients With Acute Coronary Syndrome and de Novo Coronary Artery Lesions RECRUITING

Related PubMed Literature

PMID: 41804390 Modeling In-Hospital Mortality Among Patients Undergoing Percutaneous Coronary Intervention with Acute Myocardial Infarction Complicated by Cardiogenic Shock Receiving Mechanical Circulatory Support. Medical devices (Auckland, N.Z.) (2026) PMID: 41518328 Surface Energy and Pinning Forces of Fluorine-Free, Water-Friendly Coatings for Medical Devices. Langmuir : the ACS journal of surfaces and colloids (2026) PMID: 41358283 Modeling In-Hospital Mortality Among Patients Undergoing Percutaneous Coronary Intervention with Acute Myocardial Infarction Complicated by Cardiogenic Shock Receiving Mechanical Circulatory Support. medRxiv : the preprint server for health sciences (2025)

Other Devices by B. Braun Interventional Systems, Inc.

K152765VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM

Related Devices (Code: LOX)

K163200Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation CatheteBoston Scientific Corporation K163174Emerge PTCA Dilatation CatheterBoston Scientific Corporation K160985Pantera ProBiotronik, Inc. K162209Sapphire NC PlusOrbusneich Medical, Inc. K153742Apollo Balloon Dilatation CatheterBrosmed Medical Co., Ltd. K160961Mozec NC-Rx PTCA Baloon Dilatation CatheterMeril Life Sciences Private Limited

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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