LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2
FDA 510(k) clearance K113213 · decided 2011-12-05
Clearance details
- K-number
- K113213
- Device name
- LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2
- Applicant
- Biosense Webster, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-11-01
- Decision date
- 2011-12-05
- Days to decision
- 34 days
- Clearance type
- Special
- Product code
- DRF
- Device class
- 2
- Regulation number
- 870.1220
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Diamond Bar, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysio recall (Z-1617-2013) | Biosense Webster, Inc. | 2013-06-28 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Dual Energy THERMOCOOL SMARTTOUCH SF System (P030031/S141) | Biosense Webster, Inc. | 2026-07-01 |
| VARIPULSE Catheter, TRUPULSE Generator with Connection Interface Unit (CIU) (P240006/S016) | Biosense Webster, Inc. | 2026-06-30 |
| VISITAG SURPOINT External Processing Unit (EPU); CARTO 3 System (P030031/S143) | Biosense Webster, Inc. | 2026-06-30 |
| THERMOCOOL SMARTTOUCH SF (Uni-Directional and Bi-Directional)/DUAL ENERGYTHERMOCOOL SMARTTOUCH SF CATHETERS (P030031/S144) | Biosense Webster, Inc. | 2026-06-10 |
| QDOT MICRO System (P210027/S016) | Biosense Webster, Inc. | 2026-04-17 |
| VARIPULSE Platform (VARIPULSE Catheter; TRUPULSE Generator; Sterile Interface Cable; nGEN Pump) (P240006/S014) | Biosense Webster, Inc. | 2026-02-12 |
| VARIPULSE Catheter; TRUPULSE Generator; Sterile Interface Cable; nGEN Pump (P240006/S013) | Biosense Webster, Inc. | 2026-01-02 |
| TRUPULSE Generator (P240006/S012) | Biosense Webster, Inc. | 2025-12-23 |