OPTRELL Mapping Catheter with TRUEref Technology
FDA 510(k) clearance K211438 · decided 2022-03-18
Clearance details
- K-number
- K211438
- Device name
- OPTRELL Mapping Catheter with TRUEref Technology
- Applicant
- Biosense Webster, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-05-10
- Decision date
- 2022-03-18
- Days to decision
- 312 days
- Clearance type
- Traditional
- Product code
- MTD
- Device class
- 2
- Regulation number
- 870.1220
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.
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 |