FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARTO® 3 EP Navigation System with Signal Processing Unit
K Number: K200484
·
Decision Nov 25, 2020
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
403
Applicant Total
20
Review Days
272
Basic Information
- Device Name
- CARTO® 3 EP Navigation System with Signal Processing Unit
- K Number
- K200484
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1425
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biosense Webster, Inc.
- Date Received
- February 27, 2020
- Decision Date
- November 25, 2020
- Product Code
- DQK
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | FDA class 2 | Cardiovascular |
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Other Clearances by Biosense Webster, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K241540 | NUVISION Ultrasound Catheter; NUVISION NAV Ultrasound Catheter | Jun 28, 2024 | Substantially Equivalent |
| K240050 | SOUNDSTAR CRYSTAL Ultrasound Catheter | Jun 12, 2024 | Substantially Equivalent |
| K231207 | CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) | Sep 7, 2023 | Substantially Equivalent |
| K231412 | CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S) | Jul 10, 2023 | Substantially Equivalent |
| K230253 | OPTRELL Mapping Catheter with TRUEref Technology | Mar 2, 2023 | Substantially Equivalent |
| K223766 | NUVISION NAV Ultrasound Catheter | Feb 16, 2023 | Substantially Equivalent |
| K223733 | CARTO® 3 EP Navigation System with CARTOSOUND 4D Version 7.4 | Feb 16, 2023 | Substantially Equivalent |
| K221112 | CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) | Aug 17, 2022 | Substantially Equivalent |
| K211438 | OPTRELL Mapping Catheter with TRUEref Technology | Mar 18, 2022 | Substantially Equivalent |
| K211219 | LASSOSTAR NAV Circular Mapping Catheter | Jan 26, 2022 | Substantially Equivalent |