Carto RMT Ep Navigation System V8
FDA 510(k) K060047 · Biosense Webster, Inc.
510(k) numberK060047
Submission
- Device name
- Carto RMT Ep Navigation System V8
- Applicant
- Biosense Webster, Inc.
Diamond Bar, CA, US - Received
- January 6, 2006
- Decision date
- June 19, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRF – Catheter, Electrode Recording, Or Probe, Electrode Recording
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1220
- Specialty
- Cardiovascular
Other 510(k)s with product code DRF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252794 | Vision-MR Diagnostic CatheterDRF · Traditional | Imricor Medical Systems, Inc. | 01/08/2026SE |
| K250590 | MAGiC Sweep EP Mapping CatheterDRF · Traditional | Stereotaxis, Inc. | 07/23/2025SE |
| K250310 | VIKING Fixed Curve Diagnostic CatheterDRF · Traditional | Boston Scientific Corporation | 06/27/2025SE |
| K240366 | EPXT Unidirectional Steerable Diagnostic Catheter; Dynamic Tip Unidirectional…DRF · Traditional | Boston Scientific Corporation | 11/01/2024SE |
| K233900 | Nordica PV Cryo Mapping CatheterDRF · Traditional | Synaptic Medical Corporation | 09/06/2024SE |
| K233397 | Cosine-10TM Diagnostic CatheterDRF · Traditional | Medtronic, Inc. | 12/02/2023SE |
| K233207 | Polaris X Unidirectional Steerable Diagnostic CatheterDRF · Special | Boston Scientific Corporation | 10/27/2023SE |
| K232651 | BLAZER Dx-20 Bidirectional Steerable Diagnostic CatheterDRF · Special | Boston Scientific Corporation | 09/29/2023SE |
| K230503 | Polaris X Catheter Cable, Blazer Dx-20 Catheter CableDRF · Traditional | Boston Scientific | 04/25/2023SE |
| K210313 | EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping CatheterDRF · Traditional | Shanghai Microport EP Medtech Co., Ltd. | 12/30/2022SE |
More from Shanghai Microport EP Medtech Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| 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 Carto RMT Ep Navigation System V8 cleared by the FDA?
Carto RMT Ep Navigation System V8 (K060047) received a 510(k) decision of Substantially Equivalent on June 19, 2006, 164 days after the submission was received.
What is the product code of K060047?
The FDA product code is DRF – Catheter, Electrode Recording, Or Probe, Electrode Recording, a Class II (moderate risk) device regulated under 21 CFR 870.1220.