PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE
FDA 510(k) clearance K030617 · decided 2003-05-21
Clearance details
- K-number
- K030617
- Device name
- PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE
- Applicant
- Boston Scientific Scimed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-02-26
- Decision date
- 2003-05-21
- Days to decision
- 84 days
- Clearance type
- Abbreviated
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Maple Grove, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Boston Scientific PT2 Light Support Guide Wire 185cm J-Tip, Catalog Number 38931-01. Sold recall (Z-1538-06) | Boston Scientific | 2006-09-29 |
| Boston Scientific PT2 Light Support Guide Wire 300cm J-Tip, Catalog Number 38931-02 . Sold recall (Z-1539-06) | Boston Scientific | 2006-09-29 |
| Boston Scientific PT2 Moderate Support Guide Wire 185cm J-Tip, Catalog Number 38931-03 . S recall (Z-1540-06) | Boston Scientific | 2006-09-29 |
| Boston Scientific PT2 Moderate Support Guide Wire 300cm J-Tip, Catalog Number 38931-04. So recall (Z-1541-06) | Boston Scientific | 2006-09-29 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| WALLSTENT ILIAC RP Endoprosthesis (P940019/S066) | Boston Scientific Scimed, Inc. | 2024-06-27 |
| Wallstent ILIAC RP Endoprosthesis (P940019/S065) | Boston Scientific Scimed, Inc. | 2024-03-13 |
| WALLSTENT ILIAC RP Endoprosthesis (P940019/S064) | Boston Scientific Scimed, Inc. | 2024-02-20 |
| WALLSTENT ILIAC RP Endoprosthesis (P940019/S063) | Boston Scientific Scimed, Inc. | 2023-06-14 |
| WALLSTENT ILIAC RP Endoprosthesis (P940019/S062) | Boston Scientific Scimed, Inc. | 2022-11-28 |
| WALLSTENT ILIAC RP Endoprosthesis (P940019/S061) | Boston Scientific Scimed, Inc. | 2022-11-22 |
| WALLSTENT ILIAC RP Endoprosthesis (P940019/S060) | Boston Scientific Scimed, Inc. | 2022-06-28 |
| Wallstent Iliac Endoprosthesis With Unistep Plus Delivery System (P940019/S059) | Boston Scientific Scimed, Inc. | 2020-07-22 |