OptiMap Catheter - 50mm (OPTI-CATH2-50)
FDA 510(k) K253205 · Cortex, Inc.
510(k) numberK253205
Submission
- Device name
- OptiMap Catheter - 50mm (OPTI-CATH2-50)
- Applicant
- Cortex, Inc.
Santa Clara, CA, US - Received
- September 26, 2025
- Decision date
- March 13, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MTD – Catheter, Intracardiac Mapping, High-Density Array
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1220
- Specialty
- Cardiovascular
Other 510(k)s with product code MTD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261012 | OptiMap Catheter - 60mm (OPTI-CATH2-60)MTD · Special | Cortex, Inc. | 04/23/2026SE |
| K233433 | Sphere-9Dx Diagnostic Catheter (AFR-00009)MTD · Traditional | Medtronic | 08/07/2024SE |
| K241372 | Advisor HD Grid X Mapping Catheter, Sensor EnabledMTD · Special | Abbott Medical | 07/09/2024SE |
| K231312 | PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS…MTD · Special | Biosense Webster, Inc. | 07/10/2023SE |
| K223666 | Ablacath Mapping CatheterMTD · Traditional | Ablacon, Inc. | 03/17/2023SE |
| K230253 | OPTRELL Mapping Catheter with TRUEref TechnologyMTD · Special | Biosense Webster, Inc. | 03/02/2023SE |
| K210766 | AcQMap 3D Imaging and Mapping Catheter, Model 900009MTD · Traditional | Acutus Medical, Inc. | 06/21/2022SE |
| K211438 | OPTRELL Mapping Catheter with TRUEref TechnologyMTD · Traditional | Biosense Webster, Inc. | 03/18/2022SE |
| K201806 | Reprocessed PentaRay Nav eco High-Density Mapping CatheterMTD · Traditional | Sterilmed Inc. (Johnson and Johnson) | 06/23/2021SE |
| K201341 | AcQMap 3D Imaging and Mapping CatheterMTD · Traditional | Acutus Medical, Inc. | 09/15/2020SE |
More from Acutus Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261012 | OptiMap Catheter - 60mm (OPTI-CATH2-60)MTD · Special | 04/23/2026SE |
Questions and answers
When was OptiMap Catheter - 50mm (OPTI-CATH2-50) cleared by the FDA?
OptiMap Catheter - 50mm (OPTI-CATH2-50) (K253205) received a 510(k) decision of Substantially Equivalent on March 13, 2026, 168 days after the submission was received.
What is the product code of K253205?
The FDA product code is MTD – Catheter, Intracardiac Mapping, High-Density Array, a Class II (moderate risk) device regulated under 21 CFR 870.1220.