Enquirer Consulting Group

AP Technologies Catheter OEM Map

Prepared for Russell | AP Technologies | October 2026

As of Oct 11, 2026. Counts from federal device clearance and approval records published by October 10, 2026, described in the notes at the foot

You told Natoya the market your team cares about is small, and that it is supply chain and engineering executives more than buyers. This page counts the companies where those people could sit: medical device makers that took a catheter-family product through FDA 510(k) clearance in the last five years, split by the kind of catheter, so you can point at the rows that are your market. It is built from public federal records. No public record names the supply chain or engineering lead at a company, and nothing here says who already works with AP Technologies.

Companies with a catheter-family 510(k) clearance in the last five years

280

October 2021 to October 2026, every country.

Of those, based in the United States

180

By the applicant's address on the clearance.

Applicant names new to the list in the last 12 months

about 50

Their first catheter-family clearance in the five years came after October 10, 2025.

Applicant names with a class III catheter decision in the last two years

about 20

Premarket approvals and their supplements, October 2024 to October 2026. Not all of them are among the 510(k) companies above.

Companies by kind of catheter

Device makers with at least one 510(k) clearance in the group, October 2021 to October 2026.

A company that cleared products in two groups is counted in each, so the rows add to more than the 280 companies in the tiles.
Kind of catheter	Companies	In the US	What is in it
Coronary and peripheral vascular	150	100	Diagnostic and guide catheters, angioplasty, atherectomy, thrombectomy, crossing and imaging catheters.
Introducers, sheaths and guidewires	about 70	about 50	The access tools that go in ahead of the catheter.
Neurovascular	about 40	about 30	Neurovascular catheters and guidewires, carotid embolic capture.
Urology and GI	about 40	about 20	Urinary, nephrostomy, biliary, drainage and balloon retention catheters.
Vascular access	about 30	about 30	Short and long term intravascular catheters, hemodialysis catheters, midlines and implanted ports.
Electrophysiology, mapping and steerable	about 20	about 10	Recording and mapping catheters, steerable catheters and their control systems.
Other	about 10	under 10	Anesthesia, reproductive and other catheters.

Companies by how often they file

The same companies by the number of catheter-family clearances each took in the five years.

One clearance in five years usually means a single catheter product under that name. Five or more means steady catheter filing, often across several products and their updates.
Clearances in five years	Companies	In the US
One	140	about 80
Two to four	about 90	about 60
Five or more	about 50	about 40
All	280	180

Who carries the supplier decision

The two groups you named, and the titles they usually sit under at a device maker. At a smaller company one person can hold two of them.

Role	Where they sit
VP or Director of Supply Chain	Owns which outside partners carry a product line once it is in production.
Supplier Quality or Supplier Development lead	Qualifies a new supplier and keeps it qualified.
VP of R&D or Engineering	Owns the development program and the partners it is built with.
Principal or catheter R&D engineer, program manager	Shapes how a new device is built while it is still in development.

What no public count reaches

Three things this page cannot size from public records, said in words rather than shown as numbers.

The people. No public register counts supply chain or engineering executives, so this page counts the companies they work at.

Who builds for whom. A clearance names the company that holds it, not the contract manufacturer behind it. FDA establishment listings show some contract manufacturers of finished devices, but component and subassembly suppliers usually do not have to register, so no public record gives a full picture of who outsources catheter work or to whom.

Programs not yet cleared. A company still in development has no clearance to count, so the earliest programs only appear here once their first device clears.

Three openings

Where the counts point.

Neurovascular is running ahead.

Neurovascular catheter and guidewire clearances from January 1 to October 10, 2026 are at least double the count for the same months of any year from 2022 to 2025. About 40 companies took one in the five years, 30 of them in the US.

The new names.

About 50 applicant names, 30 of them in the US, took their first catheter-family clearance of the five years in the last 12 months. About 40 of them have no earlier 510(k) of any kind on record under that name, though a few of those are new units of large groups. For a young company, a first clearance is often when it settles who will build its device.

The class III programs.

About 20 applicant names had a premarket approval decision on a catheter in the last two years, split between ablation and coronary or peripheral work. Most decisions are supplements to devices already on the market, and a handful are first approvals of new ablation and drug-coated balloon systems.

Denominators, definitions and sources

Catheter-family products are every FDA device product code whose device name contains the word catheter (222 codes), which takes in catheter introducers and catheter guidewires. Codes for reprocessed devices are left out, because a reprocessor does not build new catheters. The kind of catheter is our plain grouping of those codes.
Companies are 510(k) applicants with a decision dated October 1, 2021 to October 10, 2026; the latest decision published in that window is dated September 23, 2026. They are counted by applicant name, with spelling variants of one name merged, so a group that files under two company names counts twice. A few De Novo grants on the same codes are counted with the clearances. Contract manufacturers we could identify among the applicants are left out, because they are peers rather than buyers. In the US means the applicant's address on at least one clearance is in the United States.
Class III means premarket approval decisions, original approvals and supplements, on the same product codes, dated October 11, 2024 to October 10, 2026, counted by applicant name. The neurovascular comparison counts clearances dated January 1 to October 10 in each year, so every year is compared over the same months.
Built from public federal records, counts banded deliberately. Figures of 100 and over are rounded to two significant figures, figures from 10 to 99 to the nearest ten, and figures below 10 are shown as under 10.

The named version of this page, the actual companies inside a row and the supply chain and engineering leads at each, is built one row at a time. If you want to walk through a row together, pick a time at cal.com/ecg. Prepared by Dan Reeves, dan@enquirerconsulting.com.

Enquirer Consulting Group | enquirerconsulting.com