KardiFlex PTCA Balloon Dilatation Catheter

Q: What is the product code of K202619?

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) K202619 · Medcaptain Life Science Co., Ltd.

Substantially Equivalent

510(k) numberK202619

Submission

Device name: KardiFlex PTCA Balloon Dilatation Catheter
Applicant: Medcaptain Life Science Co., Ltd.
Shenzhen, CN
Received: September 10, 2020
Decision date: April 29, 2021
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

510(k)	Device	Decision
K230528	Extension SetFPA · Traditional	12/01/2023SE
K213004	Needle Free ConnectorFPA · Traditional	05/10/2022SE
K202578	KardiFlex NC Coronary Dilatation CatheterLOX · Traditional	05/06/2021SE
K202748	Enteral Feeding CatheterKNT · Traditional	04/09/2021SE

Questions and answers

When was KardiFlex PTCA Balloon Dilatation Catheter cleared by the FDA?

KardiFlex PTCA Balloon Dilatation Catheter (K202619) received a 510(k) decision of Substantially Equivalent on April 29, 2021, 231 days after the submission was received.

What is the product code of K202619?

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