OptiMap Catheter - 60mm (OPTI-CATH2-60)— 510(k) K261012
Substantially EquivalentCortex, Inc.
FDA 510(k) clearance K261012 for OptiMap Catheter - 60mm (OPTI-CATH2-60), Substantially Equivalent on 2026-04-23. Applicant: Cortex, Inc.. Device class: 2.
Summary
Cortex, Inc.'s OptiMap Catheter - 60mm (OPTI-CATH2-60) is filed under product code MTD (Catheter, Intracardiac Mapping, High-Density Array).
Class II, 21 CFR 870.1220. Cardiovascular is both the classification panel and the review panel, and it came in as a Special 510(k).
Cortex filed from Santa Clara, California. The decision came 27 calendar days after FDA received it (March 27 to April 23, 2026).
Clearance details
- Applicant
- Cortex, Inc.
- Product code
- Product code MTD
- Device class
- Class 2
- Regulation
- 21 CFR 870.1220
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Santa Clara, CA, US
Recent devices under product code MTD
view all- K253205 — OptiMap Catheter - 50mm (OPTI-CATH2-50)
- K233433 — Sphere-9Dx Diagnostic Catheter (AFR-00009)
- K241372 — Advisor HD Grid X Mapping Catheter, Sensor Enabled
- K231312 — 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
- K223666 — Ablacath Mapping Catheter
Adverse events under product code MTD
product code MTD- Death
- 22
- Injury
- 376
- Malfunction
- 986
- Total
- 1,384
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.