GORE(R) EMBOLIC FILTER
FDA 510(k) clearance K120480 · decided 2012-03-16
Clearance details
- K-number
- K120480
- Device name
- GORE(R) EMBOLIC FILTER
- Applicant
- W.L. Gore & Associates
- Decision
- Substantially Equivalent
- Date received
- 2012-02-16
- Decision date
- 2012-03-16
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- NTE
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Flagstaff, AZ, US
- Third-party review
- No
- Expedited review
- No
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| 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 |
| EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (K141678) | Abbott Vascular | 2014-07-22 |
Recalls involving this device
No recalls on record reference this clearance.