CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES
FDA 510(k) clearance K090017 · decided 2009-10-13
Clearance details
- K-number
- K090017
- Device name
- CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES
- Applicant
- Biosense Webster, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-01-02
- Decision date
- 2009-10-13
- Days to decision
- 284 days
- Clearance type
- Traditional
- Product code
- DQK
- Device class
- 2
- Regulation number
- 870.1425
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Diamond Bar, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for catheter-based atrial recall (Z-2369-2012) | Biosense Webster, Inc. | 2012-09-12 |
| CARTO 3 Systems, Product Code M-4800-01 The intended use of the CARTO 3 System is catheter recall (Z-1230-2012) | Biosense Webster, Inc. | 2012-03-20 |
| 10 ft. Interface Cable, 10 Pin - Shielded Tip Pins to 12 Pin - Blue, Manufacturing Part Nu recall (Z-1839-2011) | Biosense Webster, Inc. | 2011-03-28 |
| CARTO 3 System Interface Cable, 34-pin to 10-pin, Red, 10' - Part Number: D-1286-18; Catal recall (Z-0884-2011) | Biosense Webster, Inc. | 2011-01-07 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| TRUPULSE Generator (P240006/S012) | Biosense Webster, Inc. | 2025-12-23 |
| nGEN Pump (P990071/S068) | Biosense Webster, Inc. | 2025-12-23 |
| SMARTABLATE System Interface Cable (D-1303-02-S) (P990071/S067) | Biosense Webster, Inc. | 2025-09-15 |
| VARIPULSE Catheter (P240006/S011) | Biosense Webster, Inc. | 2025-09-10 |
| VARIPULSE Platform; VARIPULSE Catheter; TRUPULSE Generator; Sterile Interface Cable; nGEN Pump (P240006/S010) | Biosense Webster, Inc. | 2025-08-07 |
| VARIPULSE Platform (P240006/S009) | Biosense Webster, Inc. | 2025-07-23 |
| VARIPULSE Platform (VARIPULSE Catheter; TRUPULSE Generator; Sterile Interface Cable; nGEN Pump) (P240006/S007) | Biosense Webster, Inc. | 2025-06-26 |
| VARIPULSE Bi-Directional Catheter (P240006/S008) | Biosense Webster, Inc. | 2025-06-05 |