PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M
FDA 510(k) clearance K001139 · decided 2000-05-10
Clearance details
- K-number
- K001139
- Device name
- PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M
- Applicant
- Biosense Webster, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-04-10
- Decision date
- 2000-05-10
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- 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 |
|---|---|---|
| Biosense Webster PREFACE Guiding Sheath, Multipurpose Short, for the introduction of intra recall (Z-0537-2007) | Biosense Webster, Inc. | 2007-02-28 |
| Biosense Webster PREFACE Guiding Sheath, Multipurpose 62cm, for the introduction of intrav recall (Z-0538-2007) | Biosense Webster, Inc. | 2007-02-28 |
| Biosense Webster PREFACE Guiding Sheath, Multipurpose 77cm, for the introduction of intrav recall (Z-0539-2007) | Biosense Webster, Inc. | 2007-02-28 |
| Biosense Webster PREFACE Guiding Sheath, Anterior, for the introduction of intravascular e recall (Z-0540-2007) | Biosense Webster, Inc. | 2007-02-28 |
| Biosense Webster PREFACE Guiding Sheath, Posterior, for the introduction of intravascular recall (Z-0541-2007) | Biosense Webster, Inc. | 2007-02-28 |
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 |