NC TREK NEO Coronary Dilatation Catheter

Q: What is the product code of K220634?

The FDA product code is LOX – Catheters, Transluminal Coronary Angioplasty, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.5100.

FDA 510(k) K220634 · Abbott Vascular

Substantially Equivalent

510(k) numberK220634

Submission

Device name: NC TREK NEO Coronary Dilatation Catheter
Applicant: Abbott Vascular
Santa Clara, CA, US
Received: March 4, 2022
Decision date: June 30, 2022
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: LOX – Catheters, Transluminal Coronary Angioplasty, Percutaneous
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.5100
Specialty: Cardiovascular

A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end.

Other 510(k)s with product code LOX

510(k)	Device	Applicant	Decision
K261428	NC Euphora Rapid Exchange Balloon Dilatation CatheterLOX · Traditional	Medtronic Ireland	08/14/2026SE
K261759	Euphora Rapid Exchange (RX) Balloon Dilatation CatheterLOX · Traditional	Medtronic Ireland	07/27/2026SE
K252116	Firefighter Pro PTCA Balloon CatheterLOX · Traditional	Shanghai MicroPort Medical (Group) Co., Ltd.	04/07/2026SE
K254022	FLASH Flex Aorto-Ostial Angioplasty SystemLOX · Traditional	Verge Medical, Inc.	04/02/2026SE
K252295	RyureiLOX · Traditional	Terumo Corporation	03/27/2026SE
K251970	Sprinter Legend Rapid Exchange Balloon Dilatation CatheterLOX · Traditional	Medtronic, Ireland	01/17/2026SE
K242969	Pantera Pro; Pantera LEOLOX · Special	Biotronik, Inc.	10/25/2024SE
K233499	Sapphire NC ULTRA Coronary Dilatation CatheterLOX · Traditional	OrbusNeich Medical (Shenzhen) Co., Ltd.	08/16/2024SE
K233505	Sapphire ULTRA Coronary Dilatation CatheterLOX · Traditional	OrbusNeich Medical (Shenzhen) Co., Ltd.	08/15/2024SE
K233729	Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon…LOX · Traditional	Vascular Solutions, LLC	05/31/2024SE

More from Vascular Solutions, LLC

510(k)	Device	Decision
K221057	Viatrac 14 Plus Peripheral Dilatation CatheterLIT · Special	05/05/2022SE
K201834	HI-TORQUE PROCEED Guide Wire FamilyDQX · Special	07/30/2020SE
K200144	HI-TORQUE Steelcore Bare Guide WireDQX · Traditional	04/08/2020SE
K193126	HI-TORQUE InfilTrac Guide Wire FamilyDQX · Special	12/11/2019SE
K191173	Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery WiresNTE · Traditional	07/25/2019SE
K180040	NC TREK RX Coronary Dilatation Catheter; NC TREK OTW Coronary Dilatation Catheter…LOX · Special	08/24/2018SE
K173795	HI-TORQUE TurnTrac Guide Wire FamilyDQX · Special	01/12/2018SE
K172394	Steerable Guide CatheterDRA · Special	09/06/2017SE
K172073	Hi-Torque Command 18 Guide WireDQX · Special	08/25/2017SE
K161985	Steerable Guide CatheterDRA · Special	08/07/2016SE

Questions and answers

When was NC TREK NEO Coronary Dilatation Catheter cleared by the FDA?

NC TREK NEO Coronary Dilatation Catheter (K220634) received a 510(k) decision of Substantially Equivalent on June 30, 2022, 118 days after the submission was received.

What is the product code of K220634?

The FDA product code is LOX – Catheters, Transluminal Coronary Angioplasty, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.5100.