NAVISTAR RMT THERMOCOOL DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER
FDA premarket approval P040036/S009 · decided 2008-11-07
Approval details
- PMA number
- P040036
- Supplement
- S009
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NAVISTAR RMT THERMOCOOL DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- Biosense Webster, Inc.
- Date received
- 2008-10-09
- Decision date
- 2008-11-07
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR TWO ADDITIONAL QUALITY CONTROL INSPECTION STEPS: 1) ADDING A 100% VISUAL INSPECTION OF THE PCB BOARDS TO VERIFY THAT ALL COMPONENTS ARE PRESENT, AND 2) ADDING AN EEPROM READ STEP DURING THE EXISTING CALIBRATION PROCESS TO VERIFY THAT ALL PCB COMPONENTS ARE PRESENT AND FUNCTIONING PROPERLY.
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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 |