CORDIS WEBSTER DIAGNOSITIC/ABLATION DEFLECTABLE TIP CATHETER & CATHETER-THERMOCOUPLE OR THERMISTOR
FDA premarket approval P950005/S003 · decided 1999-01-26
Approval details
- PMA number
- P950005
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CORDIS WEBSTER DIAGNOSITIC/ABLATION DEFLECTABLE TIP CATHETER & CATHETER-THERMOCOUPLE OR THERMISTOR
- Generic name
- CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
- Applicant
- Biosense Webster, Inc.
- Date received
- 1998-07-27
- Decision date
- 1999-01-26
- Days to decision
- 183 days
- Decision code
- APPR
- Product code
- DRF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for expanded indications for use for the 6 Fr and 7 Fr Cordis Webster Diagnostic/Ablation Deflectable Tip Catheters and interface cables. In addition to the previously approved indications for interruption of accessory AV conduction pathways associated 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 arrhythmia, your ablation system is now approved
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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 |