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FDA 510(k)

Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete

K-Number: K163200 · 2016-12-14

ApplicantBoston Scientific Corporation
Decision Date2016-12-14
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2016-12-14 under approval number K163200. 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 Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete?

Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete is a medical device that received FDA 510(k) clearance on 2016-12-14. It is manufactured by Boston Scientific Corporation. The 510(k) number is K163200.

When was Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete approved by the FDA?

Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete received FDA 510(k) clearance on 2016-12-14, under approval number K163200.

What company makes Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete?

Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete is manufactured by Boston Scientific Corporation.

What is the FDA product code for Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete?

The FDA product code for Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete 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 NCT05493904 PREcise Percutaneous Coronary Intervention for Stent OptimizatION in Treatment of COMPLEX Lesion (PRECISION-COMPLEX) ACTIVE_NOT_RECRUITING 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 NCT07588399 STRATegy SUccesS in High-Risk PCI With Impella CP: Evaluation of Hemodynamic Protection in Complex PCI NOT_YET_RECRUITING NCT04647253 A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) ACTIVE_NOT_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: 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 Boston Scientific Corporation

K163174Emerge PTCA Dilatation Catheter K162350Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018 K162404Express SD Biliary Monorail Premounted Stent System K160823NC Quantum Apex PTCA Dilatation Catheter K160514OptiCross 18, 30 MHz Peripheral Imaging Catheter K161003EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector

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Related Devices (Code: LOX)

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 K153682Chocolate XD PTCA Balloon CatheterTrireme Medical, LLC

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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