ClearanceBrief
Panels › Cardiovascular › Product code LOX · Class 2

Catheters, Transluminal Coronary Angioplasty, Percutaneous

Regulation 870.5100

6510(k)s in 12 months (88 all time)
0recalls in 12 months (121 all time)
29recalls that name a 510(k)
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Top companies in LOX

Company510(k)sRecalls
Cordis Corporation083
Abbott Vascular620
Boston Scientific106
Brosmed Medical50
Ostial Corporation50
Trireme Medical, Inc.50
Medtronic, Inc.22
Medtronic Ireland40
Medtronic Vascular Galway DBA Medtronic Ireland04
Orbusneich Medical, Inc.40
Decided510(k)Device and applicantCode
Aug 14, 2026K261428NC Euphora Rapid Exchange Balloon Dilatation Catheter
Medtronic Ireland, IE
LOX
Jul 27, 2026K261759Euphora Rapid Exchange (RX) Balloon Dilatation Catheter
Medtronic Ireland, IE
LOX
Apr 7, 2026K252116Firefighter™ Pro PTCA Balloon Catheter
Shanghai MicroPort Medical (Group) Co., Ltd., CN
LOX
Apr 2, 2026K254022FLASH Flex™ Aorto-Ostial Angioplasty System
Verge Medical, Inc.
LOX
Mar 27, 2026K252295Ryurei
Terumo Corporation, JP
LOX
Jan 17, 2026K251970Sprinter Legend Rapid Exchange Balloon Dilatation Catheter
Medtronic, Ireland, IE
LOX
Oct 25, 2024K242969Pantera Pro; Pantera LEO
Biotronik, Inc.
LOX
Aug 16, 2024K233499Sapphire NC ULTRA Coronary Dilatation Catheter
OrbusNeich Medical (Shenzhen) Co., Ltd., CN
LOX
Aug 15, 2024K233505Sapphire ULTRA Coronary Dilatation Catheter
OrbusNeich Medical (Shenzhen) Co., Ltd., CN
LOX
May 31, 2024K233729Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon catheter, 2.50 x 20mm (5882); Ringer per
Vascular Solutions, LLC
LOX
Jul 21, 2023K223189Firefighter™ NC Pro PTCA Balloon Catheter
Shanghai MicroPort Medical (Group) Co., Ltd., CN
LOX
Jun 29, 2023K230374Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dil
Dongguan TT Medical, Inc., CN
LOX
Apr 11, 2023K230705POT PTCA Balloon Dilatation Catheter
Brosmed Medical Co., Ltd., CN
LOX
Feb 15, 2023K223022SC HONKYTONK PTCA Balloon Dilatation Catheter
Sino Medical Sciences Technology, Inc., CN
LOX
Dec 21, 2022K222538NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter
Sino Medical Sciences Technology, Inc., CN
LOX
Jun 30, 2022K220634NC TREK NEO Coronary Dilatation Catheter
Abbott Vascular
LOX
Mar 24, 2022K220629Emerge Monorail PTCA Dilatation Catheter
Boston Scientific, IE
LOX
Mar 14, 2022K212393OPN NC PTCA Dilatation Catheter
Sis Medical AG, CH
LOX
Jan 7, 2022K211349Selebrek PTCA Balloon Dilatation Catheter
Kossel Medtech (Suzhou) Co., Ltd., CN
LOX
Oct 14, 2021K211807Sapphire NC 24
OrbusNeich Medical (Shenzhen) Co., Ltd., CN
LOX
Jul 9, 2021K210012Tamarin Blue PTCA RX Dilatation Catheter
Natec Medical , Ltd., MU
LOX
Jul 2, 2021K211393Selethru(TM) NC PTCA Balloon Dilatation Catheter
Kossel Medtech (Suzhou) Co., Ltd., CN
LOX
May 6, 2021K202578KardiFlex NC Coronary Dilatation Catheter
Medcaptain Life Science Co., Ltd., CN
LOX
Apr 29, 2021K202619KardiFlex PTCA Balloon Dilatation Catheter
Medcaptain Life Science Co., Ltd., CN
LOX
Apr 14, 2021K203390Artimes pro Balloon Dilatation Catheter
Brosmed Medical Co., Ltd., CN
LOX
Mar 4, 2020K200269Sapphire II PRO
Orbusneich Medical Trading, Inc.
LOX
Sep 19, 2019K192344Sapphire NC Plus Coronary Dilatation Catheter
Orbusneich Medical Trading, Inc.
LOX
Nov 26, 2018K182699Selethru PTCA Balloon Dilatation Catheter
Kossel Medtech (Suzhou) Co., Ltd., CN
LOX
Aug 24, 2018K180040NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary Dilatation Catheter; TREK™ RX Coronary Dilatation Cathet
Abbott Vascular
LOX
Jun 28, 2018K180921Sapphire II PRO Balloon Dilatation Catheter
Orbusneich Medical Trading, Inc.
LOX
May 17, 2018K181023Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation Catheter
Meril Life Sciences Private Limited, IN
LOX
Mar 19, 2018K172264OTW Takeru PTCA Balloon Dilatation Catheter
KANEKA Corporation, JP
LOX
Mar 1, 2018K173680Sapphire II PRO
Orbusneich Medical Trading, Inc.
LOX
Jan 25, 2018K173581Gallant PTCA Dilatation Catheter
Medinol, Ltd., IL
LOX
Jul 7, 2017K170941RX NC Takeru PTCA Balloon Dilatation Catheter
KANEKA Corporation, JP
LOX
Jun 12, 2017K162625SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters
B. Braun Interventional Systems, Inc.
LOX
Apr 7, 2017K163372RX Takeru Balloon Dilatation Catheter
KANEKA Corporation, JP
LOX
Jan 26, 2017K163660Pantera LEO
Biotronik, Inc.
LOX
Jan 19, 2017K162434NC Gallant PTCA Catheter
Medinol, Ltd., IL
LOX
Jan 5, 2017K163114Sapphire II PRO
Orbusneich Medical, Inc.
LOX
Dec 14, 2016K163200Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete
Boston Scientific Corporation
LOX
Dec 14, 2016K163174Emerge PTCA Dilatation Catheter
Boston Scientific Corporation
LOX
Oct 7, 2016K160985Pantera Pro
Biotronik, Inc.
LOX
Oct 6, 2016K162209Sapphire NC Plus
Orbusneich Medical, Inc.
LOX
Aug 8, 2016K153742Apollo Balloon Dilatation Catheter
Brosmed Medical Co., Ltd., CN
LOX
Jul 30, 2016K160961Mozec NC-Rx PTCA Baloon Dilatation Catheter
Meril Life Sciences Private Limited, IN
LOX
Jun 23, 2016K160823NC Quantum Apex PTCA Dilatation Catheter
Boston Scientific Corporation
LOX
Jun 23, 2016K153682Chocolate XD PTCA Balloon Catheter
Trireme Medical, LLC
LOX
Feb 16, 2016K152485FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x 135cm, FLASH Mini Ostial System
Ostial Corporation
LOX
Jun 28, 2015K141933FILAO NC RX PTCA DILATATION CATHETER
Natec Medical , Ltd.
LOX

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