FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPTRELL Mapping Catheter with TRUEref Technology
K Number: K230253
·
Decision Mar 2, 2023
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
33
Applicant Total
73
Review Days
30
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Basic Information
- Device Name
- OPTRELL Mapping Catheter with TRUEref Technology
- K Number
- K230253
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1220
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biosense Webster, Inc.
- Date Received
- January 31, 2023
- Decision Date
- March 2, 2023
- Product Code
- MTD
- 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 |
|---|---|---|---|
| MTD | Catheter, Intracardiac Mapping, High-Density Array | FDA class 2 | Cardiovascular |
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Other Clearances by Biosense Webster, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252972 | CARTO 3 EP Navigation System V8.4 | Feb 20, 2026 | Substantially Equivalent |
| K254085 | CARTO 3 EP Navigation System V9.0 with PIU Plus | Jan 18, 2026 | Substantially Equivalent |
| K252302 | CARTO 3 EP Navigation System V8.1 | Aug 22, 2025 | Substantially Equivalent |
| 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 |
| 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 | Jul 10, 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 |
| 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 |