STOCKERT 70 RADIOFREQUENCY GENERATOR
FDA premarket approval P990071/S004 · decided 2004-02-24
Approval details
- PMA number
- P990071
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- STOCKERT 70 RADIOFREQUENCY GENERATOR
- Generic name
- CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
- Applicant
- Biosense Webster, Inc.
- Date received
- 2003-11-05
- Decision date
- 2004-02-24
- Days to decision
- 111 days
- Decision code
- APPR
- Product code
- DRF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE ADDITION OF A STOCKERT REMOTE CONTROL AND CONNECTION CABLE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STOCKERT REMOTE CONTROL AND CONNECTION CABLE AND IS INDICATED FOR USE IN CONJUNCTION WITH THE STOCKERT 70 RADIOFREQUENCY GENERATOR TO BE USED IN CONJUNCTION WITH A COMPATIBLE CATHETER FOR CARDIAC ABLATION PROCEDURES.
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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 |