FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (3.5 MM TO 5.5 MM)
FDA 510(k) clearance K063313 · decided 2006-12-05
Clearance details
- K-number
- K063313
- Device name
- FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (3.5 MM TO 5.5 MM)
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2006-11-02
- Decision date
- 2006-12-05
- Days to decision
- 33 days
- Clearance type
- Traditional
- Product code
- NTE
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
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| WIRION (K200198) | Cardiovascular Systems, Inc. | 2020-03-18 |
| Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires (K191173) | Abbott Vascular | 2019-07-25 |
| WIRION (K180023) | Gardia Medical , Ltd. | 2018-03-21 |
| ENROUTE Transcarotid Neuroprotection System (K153485) | Silk Road Medical, Inc. | 2016-03-10 |
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| WIRION (K143570) | Gardia Medical | 2015-06-04 |
| ENROUTE Transcarotid Neuroprotection System (K143072) | Silk Road Medical, Inc. | 2015-02-09 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 190cm, 3.5-5.5 mm, recall (Z-0105-2009) | Boston Scientific Corporation | 2008-10-14 |
| Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 300cm, 3.5-5.5 mm, recall (Z-0106-2009) | Boston Scientific Corporation | 2008-10-14 |
| Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 190cm, 3.5-5.5 mm, recall (Z-0107-2009) | Boston Scientific Corporation | 2008-10-14 |
| Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 300cm, 3.5-5.5 mm, recall (Z-0108-2009) | Boston Scientific Corporation | 2008-10-14 |
| Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 190cm, 3.5-5.5 mm, recall (Z-0109-2009) | Boston Scientific Corporation | 2008-10-14 |
| Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 300cm, 3.5-5.5 mm, recall (Z-0110-2009) | Boston Scientific Corporation | 2008-10-14 |