MTD · Catheter, Intracardiac Mapping, High-Density Array

Device class

Class II

Regulation 870.1220

Total clearances

2020-07-31 → 2026-04-23

Last 12 months

Unique sponsors

Classification details

Medical specialty

Cardiovascular

Review panel

Regulation number

870.1220

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Biosense Webster, Inc.	5	0	2023-07-10
Cortex, Inc.	2	2	2026-04-23
Acutus Medical, Inc.	2	0	2022-06-21
ABBOTT MEDICAL	1	0	2024-07-09
Medtronic	1	0	2024-08-07
Innovative Health, LLC	1	0	2020-09-03
Ablacon, Inc.	1	0	2023-03-17
Sterilmed Inc. (Johnson and Johnson)	1	0	2021-06-23

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
93609	CPT	—	High	CPT for intraventricular catheter placement for electrophysiologic mapping
93613	CPT	—	Medium	CPT for left ventricular mapping during ablation procedure

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-04-23	K261012	Cortex, Inc.	OptiMap Catheter - 60mm (OPTI-CATH2-60)
2026-03-13	K253205	Cortex, Inc.	OptiMap Catheter - 50mm (OPTI-CATH2-50)
2024-08-07	K233433	Medtronic	Sphere-9Dx Diagnostic Catheter (AFR-00009)
2024-07-09	K241372	ABBOTT MEDICAL	Advisor HD Grid X Mapping Catheter, Sensor Enabled
2023-07-10	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
2023-03-17	K223666	Ablacon, Inc.	Ablacath Mapping Catheter
2023-03-02	K230253	Biosense Webster, Inc.	OPTRELL Mapping Catheter with TRUEref Technology
2022-06-21	K210766	Acutus Medical, Inc.	AcQMap 3D Imaging and Mapping Catheter, Model 900009
2022-03-18	K211438	Biosense Webster, Inc.	OPTRELL Mapping Catheter with TRUEref Technology
2021-06-23	K201806	Sterilmed Inc. (Johnson and Johnson)	Reprocessed PentaRay Nav eco High-Density Mapping Catheter
2020-09-15	K201341	Acutus Medical, Inc.	AcQMap 3D Imaging and Mapping Catheter
2020-09-03	K200212	Innovative Health, LLC	Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled
2020-08-06	K201750	Biosense Webster, Inc.	Pentaray Nav eco High-Density Mapping Catheter
2020-07-31	K193237	Biosense Webster, Inc.	Carto Octaray Mapping Catheter with Trueref Technology