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FDA 510(k), K163154, Traxcess 7 Mini XSoft Guidewire
FDA 510(k), K163154, Traxcess 7 Mini XSoft Guidewire
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510(K) Number: K163154
Device Name: Traxcess 7 Mini XSoft Guidewire
Manufacturer: MicroVention, Inc.
Device Classification Name: guide, wire, catheter, neurovasculature
Regulation Number: 870.1330
Classification Product Code: MOF
Date Received: 11/10/2016
Decision Date: 12/09/2016
Regulation Medical Specialty: Cardiovascular
Device Name: Traxcess 7 Mini XSoft Guidewire
Manufacturer: MicroVention, Inc.
Device Classification Name: guide, wire, catheter, neurovasculature
Regulation Number: 870.1330
Classification Product Code: MOF
Date Received: 11/10/2016
Decision Date: 12/09/2016
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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