FDA product code LOX: Catheters, Transluminal Coronary Angioplasty, Percutaneous

LOX is the FDA product code for catheters, transluminal coronary angioplasty, percutaneous. It is a Class II device, regulated under 21 CFR 870.5100 and reviewed by the Cardiovascular panel. FDA has cleared 88 510(k) submissions under LOX, 19 in the last five years, from 37 different applicants. The average 510(k) review took 138 days (median 120); 183 days on average over the last three years. 22 PMA applications cite this product code. FDA has posted 121 recalls for LOX devices, 1 initiated in the last five years.

Definition

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

Classification

Field	Value
Device name	Catheters, Transluminal Coronary Angioplasty, Percutaneous
Device class	Class II
Regulation	21 CFR 870.5100
Review panel	CV — Cardiovascular
Medical specialty	Cardiovascular
Premarket route	510(k)

510(k) clearances per year for LOX

Year	Clearances	Avg. review days
2017	6	120
2018	7	113
2019	1	21
2020	1	29
2021	6	164
2022	5	146
2023	4	146
2024	4	200
2026	6	166

Compare with all 510(k) review times · Search every LOX clearance

Top LOX applicants

Applicant	Clearances	Latest
Abbott Vascular	6	2022-06-30
Boston Scientific Corporation	6	2016-12-14
Ostial Corporation	5	2016-02-16
Orbusneich Medical Trading, Inc.	4	2020-03-04
Orbusneich Medical, Inc.	4	2017-01-05

32 more applicants have LOX clearances. See the full list in Caduvo.

Most recent LOX clearances

510(k)	Applicant	Device	Decision date	Review days
K261428	Medtronic Ireland	NC Euphora Rapid Exchange Balloon Dilatation Catheter	2026-08-14	106
K261759	Medtronic Ireland	Euphora Rapid Exchange (RX) Balloon Dilatation Catheter	2026-07-27	60
K252116	Shanghai MicroPort Medical (Group) Co., Ltd.	Firefighter Pro PTCA Balloon Catheter	2026-04-07	274
K254022	Verge Medical, Inc.	FLASH Flex Aorto-Ostial Angioplasty System	2026-04-02	107
K252295	Terumo Corporation	Ryurei	2026-03-27	247

Recalls for LOX devices

121 product recalls in 19 recall events; 1 initiated in the last five years and 3 still open. Most recent: 2022-06-24.

Year	Recalls
2017	5
2019	4
2020	17
2022	1

HCPCS codes with matching descriptors

Text match between the FDA device name and CMS descriptors, not an official crosswalk:

C9602 — Percutaneous transluminal coronary atherectomy, with drug eluting intracoronary stent, with coronary angioplasty when performed; single major coronary artery or branch

Frequently asked questions

What is FDA product code LOX?

LOX is the FDA product code for catheters, transluminal coronary angioplasty, percutaneous. It is a Class II device, regulated under 21 CFR 870.5100 and reviewed by the Cardiovascular panel.

What device class is LOX?

Class II, regulation 21 CFR 870.5100. Typical premarket route: 510(k).

How long does a 510(k) take for product code LOX?

Across 88 cleared submissions the average was 138 days from receipt to decision (median 120).

Which companies have the most LOX clearances?

Abbott Vascular (6); Boston Scientific Corporation (6); Ostial Corporation (5); Orbusneich Medical Trading, Inc. (4); Orbusneich Medical, Inc. (4).

Have LOX devices been recalled?

Yes: 121 product recalls across 19 recall events; the most recent began 2022-06-24.

Next steps

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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