FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S)
K Number: K231412
·
Decision Jul 10, 2023
Classifications
1
FEI Numbers
273
Registration Numbers
273
Same Product Code
701
Applicant Total
73
Review Days
55
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Basic Information
- Device Name
- CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S)
- K Number
- K231412
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biosense Webster, Inc.
- Date Received
- May 16, 2023
- Decision Date
- July 10, 2023
- Product Code
- DYB
- 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 |
|---|---|---|---|
| DYB | Introducer, Catheter | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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| K240050 | SOUNDSTAR CRYSTAL Ultrasound Catheter | Jun 12, 2024 | Substantially Equivalent |
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| 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 |