FDA Device Intelligence
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Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA product code LOX · Class 2 · Cardiovascular

3,554
Registered devices
43,512
Adverse events
121
Recalls
88
510(k) clearances

Devices with this code

NC Quantum Apex™ — BOSTON SCIENTIFIC CORPORATIONArtimes Balloon Dilatation Catheter — BrosMed Medical Co.,Ltd.SPRINTER® LEGEND — MEDTRONIC, INC.Sapphire NC 24 Coronary Dilatation Catheter — OrbusNeich Medical (ShenZhen) Co., Ltd.NC Quantum Apex™ — BOSTON SCIENTIFIC CORPORATIONSelethru PTCA Balloon Dilatation Catheter — Kossel Medtech (Suzhou) Co., Ltd.Pantera LEO — Biotronik AGApex™ — BOSTON SCIENTIFIC CORPORATIONOTW TAKERU — KANEKA CORPORATIONEmpira™ NC RX PTCA Dilatation Catheter — TACTX MEDICAL, INC.Selethru NC PTCA Balloon Dilatation Catheter — Kossel Medtech (Suzhou) Co., Ltd.Apex™ — BOSTON SCIENTIFIC CORPORATIONTAMARIN BLUE PTCA RX Dilatation Catheter — NATEC MEDICAL LTDFirefighter NC Pro — Shanghai MicroPort Medical (Group) Co., Ltd.MINI TREK™ — ABBOTT VASCULAR INC.Apex™ — BOSTON SCIENTIFIC CORPORATIONNC Quantum Apex™ — BOSTON SCIENTIFIC CORPORATIONNC Euphora™ — MEDTRONIC, INC.VexPander® — Dongguan TT Medical, Inc.Sapphire NC Plus — OrbusNeich Medical (ShenZhen) Co., Ltd.MozecTM Rx PTCA Balloon Dilatation Catheter — MERIL LIFE SCIENCES PRIVATE LIMITEDMozecTM NC Rx PTCA Balloon Dilatation Catheter — MERIL LIFE SCIENCES PRIVATE LIMITEDEmpira™ NC RX PTCA Dilatation Catheter — TACTX MEDICAL, INC.TELEFLEX — TELEFLEX INCORPORATED

Recent recalls

DateFirmReason
2022-06-24Medtronic IncLuer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging.
2020-01-29Abbott VascularCoronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29Abbott VascularCoronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29Abbott VascularCoronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29Abbott VascularCoronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29Abbott VascularCoronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29Abbott VascularCoronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29Abbott VascularCoronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29Abbott VascularCoronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29Abbott VascularCoronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.