Pentaray Nav eco High-Density Mapping Catheter
FDA 510(k) K201750 · Biosense Webster, Inc.
510(k) numberK201750
Submission
- Device name
- Pentaray Nav eco High-Density Mapping Catheter
- Applicant
- Biosense Webster, Inc.
Irvin, CA, US - Received
- June 26, 2020
- Decision date
- August 6, 2020
- 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 |
| K253205 | OptiMap Catheter - 50mm (OPTI-CATH2-50)MTD · Traditional | Cortex, Inc. | 03/13/2026SE |
| 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 |
More from Sterilmed Inc. (Johnson and Johnson)
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| K252972 | CARTO 3 EP Navigation System V8.4DQK · Traditional | 02/20/2026SE |
| K254085 | CARTO 3 EP Navigation System V9.0 with PIU PlusDQK · Special | 01/18/2026SE |
| K252302 | CARTO 3 EP Navigation System V8.1DQK · Special | 08/22/2025SE |
| K241540 | NUVISION Ultrasound Catheter; NUVISION NAV Ultrasound CatheterOBJ · Special | 06/28/2024SE |
| K240050 | SOUNDSTAR CRYSTAL Ultrasound CatheterOBJ · Special | 06/12/2024SE |
| K231207 | CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)DQK · Traditional | 09/07/2023SE |
| K231412 | CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S)DYB · Special | 07/10/2023SE |
| K231312 | PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS…MTD · Special | 07/10/2023SE |
| K230253 | OPTRELL Mapping Catheter with TRUEref TechnologyMTD · Special | 03/02/2023SE |
| K223766 | NUVISION NAV Ultrasound CatheterOBJ · Traditional | 02/16/2023SE |
Questions and answers
When was Pentaray Nav eco High-Density Mapping Catheter cleared by the FDA?
Pentaray Nav eco High-Density Mapping Catheter (K201750) received a 510(k) decision of Substantially Equivalent on August 6, 2020, 41 days after the submission was received.
What is the product code of K201750?
The FDA product code is MTD – Catheter, Intracardiac Mapping, High-Density Array, a Class II (moderate risk) device regulated under 21 CFR 870.1220.