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Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA product code LOX · Class 2 · Cardiovascular

3,559
Registered devices
43,728
Adverse events
121
Recalls
88
510(k) clearances

Devices with this code

VexPander® — Dongguan TT Medical, Inc.NC Emerge® — BOSTON SCIENTIFIC CORPORATIONSPRINTER® LEGEND — MEDTRONIC, INC.Maverick²™ — BOSTON SCIENTIFIC CORPORATIONMozecTM NC Rx PTCA Balloon Dilatation Catheter — MERIL LIFE SCIENCES PRIVATE LIMITEDNC Emerge® — BOSTON SCIENTIFIC CORPORATIONTAMARIN BLUE PTCA RX Dilatation Catheter — NATEC MEDICAL LTDArtime Balloon Dilatation Catheter — BrosMed Medical Co.,Ltd.MEDADV — MEDAS INCNC TREK — ABBOTT VASCULAR INC.SPRINTER® LEGEND — MEDTRONIC, INC.Sapphire NC ULTRA Coronary Dilatation Catheter — OrbusNeich Medical (ShenZhen) Co., Ltd.POT PTCA Balloon Dilatation Catheter — BrosMed Medical Co.,Ltd.Sprinter™ — MEDTRONIC, INC.MozecTM NC Rx PTCA Balloon Dilatation Catheter — MERIL LIFE SCIENCES PRIVATE LIMITEDNC Stormer™ OTW — MEDTRONIC, INC.Apollo Balloon Dilatation Catheter — BrosMed Medical Co.,Ltd.Quantum™ Maverick™ — BOSTON SCIENTIFIC CORPORATIONRX TAKERU — KANEKA CORPORATIONTREK — ABBOTT VASCULAR INC.Quantum™ Maverick™ — BOSTON SCIENTIFIC CORPORATIONNC TREK — ABBOTT VASCULAR INC.Pantera LEO — Biotronik AGRX TAKERU — KANEKA CORPORATION

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.