FDA product code MTD: Catheter, Intracardiac Mapping, High-Density Array
MTD is the FDA product code for catheter, intracardiac mapping, high-density array. It is a Class II device, regulated under 21 CFR 870.1220 and reviewed by the Cardiovascular panel. FDA has cleared 34 510(k) submissions under MTD, 9 in the last five years, from 16 different applicants. The average 510(k) review took 143 days (median 100); 138 days on average over the last three years. FDA has posted 9 recalls for MTD devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Intracardiac Mapping, High-Density Array |
| Device class | Class II |
| Regulation | 21 CFR 870.1220 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for MTD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 135 |
| 2018 | 1 | 258 |
| 2020 | 4 | 157 |
| 2021 | 1 | 357 |
| 2022 | 2 | 388 |
| 2023 | 3 | 65 |
| 2024 | 2 | 178 |
| 2026 | 2 | 98 |
Compare with all 510(k) review times · Search every MTD clearance
Top MTD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biosense Webster, Inc. | 8 | 2023-07-10 |
| Boston Scientific Corp | 5 | 2002-05-16 |
| Acutus Medical, Inc. | 3 | 2022-06-21 |
| Cortex, Inc. | 2 | 2026-04-23 |
| Abbott Electrophysiology | 2 | 2017-02-28 |
11 more applicants have MTD clearances. See the full list in Caduvo.
Most recent MTD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261012 | Cortex, Inc. | OptiMap Catheter - 60mm (OPTI-CATH2-60) | 2026-04-23 | 27 |
| K253205 | Cortex, Inc. | OptiMap Catheter - 50mm (OPTI-CATH2-50) | 2026-03-13 | 168 |
| K233433 | Medtronic | Sphere-9Dx Diagnostic Catheter (AFR-00009) | 2024-08-07 | 300 |
| K241372 | ABBOTT MEDICAL | Advisor HD Grid X Mapping Catheter, Sensor Enabled | 2024-07-09 | 55 |
| K231312 | Biosense Webster, Inc. | PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID | 2023-07-10 | 66 |
Recalls for MTD devices
9 product recalls in 7 recall events; 1 initiated in the last five years and 0 still open. Most recent: 2022-04-28.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2020 | 1 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code MTD?
MTD is the FDA product code for catheter, intracardiac mapping, high-density array. It is a Class II device, regulated under 21 CFR 870.1220 and reviewed by the Cardiovascular panel.
What device class is MTD?
Class II, regulation 21 CFR 870.1220. Typical premarket route: 510(k).
How long does a 510(k) take for product code MTD?
Across 34 cleared submissions the average was 143 days from receipt to decision (median 100).
Which companies have the most MTD clearances?
Biosense Webster, Inc. (8); Boston Scientific Corp (5); Acutus Medical, Inc. (3); Cortex, Inc. (2); Abbott Electrophysiology (2).
Have MTD devices been recalled?
Yes: 9 product recalls across 7 recall events; the most recent began 2022-04-28.
Next steps
- Run an FDA pathway report with predicate devices for product code MTD
- Run a recall and safety report across every MTD manufacturer
- Watch product code MTD for new clearances and recalls
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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