UNI-DIRECTIONAL CELSIUS FLTR CATHETERS (D-1355-XX S)
FDA premarket approval P010068/S031 · decided 2013-06-06
Approval details
- PMA number
- P010068
- Supplement
- S031
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- UNI-DIRECTIONAL CELSIUS FLTR CATHETERS (D-1355-XX S)
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Biosense Webster, Inc.
- Date received
- 2012-11-07
- Decision date
- 2013-06-06
- Days to decision
- 211 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR MODIFIED CATHETER DESIGNS TO THE 7FR CELSIUS AND 7FR EZ STEER DS CATHETERS TO CREATE THE 7.5FR 8 MM CELSIUS FLTR CATHETERS. THE CHANGES BEING APPROVED ARE THE INCREASED DISTAL PROFILE, LARGER CURVE PROFILE, INCREASED RANGE OF DEFLECTION, AND INCREASED DEFLECTABLE TIP DIAMETER. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES BI-DIRECTIONAL CELSIUS FLTR CATHETERS (D-1359-XX-S) AND UNI-DIRECTIONAL CELSIUS FLTR CATHETERS (D-1355-XX-S) AND ARE INDICATED FOR CATHETER-BASE
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| CARTO™ 3 EP Navigation System V8.4 (K252972) | Biosense Webster, Inc. | 2026-02-20 |
| CARTO™ 3 EP Navigation System V9.0 with PIU Plus (K254085) | Biosense Webster, Inc. | 2026-01-18 |
| CARTO™ 3 EP Navigation System V8.1 (K252302) | Biosense Webster, Inc. | 2025-08-22 |
| NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter (K241540) | Biosense Webster, Inc. | 2024-06-28 |
| SOUNDSTAR™ CRYSTAL Ultrasound Catheter (K240050) | Biosense Webster, Inc. | 2024-06-12 |
| CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) (K231207) | Biosense Webster, Inc. | 2023-09-07 |
| 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 (K231312) | Biosense Webster, Inc. | 2023-07-10 |
| CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S) (K231412) | Biosense Webster, Inc. | 2023-07-10 |