CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER WITH 5MM TIP ELECTRODE
FDA premarket approval P950005/S004 · decided 1999-04-05
Approval details
- PMA number
- P950005
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER WITH 5MM TIP ELECTRODE
- Generic name
- CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
- Applicant
- Biosense Webster, Inc.
- Date received
- 1999-02-22
- Decision date
- 1999-04-05
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- DRF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for the 7 Fr and 8 Fr catheters incorporating a 5mm tip electrode. The device, as modified, will be marketed under the trade name Celsius(TM) Diagnostic/Ablation Deflectable Braided Tip Catheter (5mm Tip Electrode) and is indicated for interruption of accessory AV conduction pathways assocated with tachycardia, the treatment of AV nodal reentrant tachycardia (AVNRT), and creation of complete AV nodal block in patients with a difficult to control ventricular response to an atrial arrhyth
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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 |
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| 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 |