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FDA 510(k), K151358, AZUR CX Detachable 35 Coils
FDA 510(k), K151358, AZUR CX Detachable 35 Coils
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510(K) Number: K151358
Device Name: AZUR CX Detachable 35 Coils
Manufacturer: Micro Vention, Inc.
Device Classification Name: Device, Vascular, For Promoting Embolization
Regulation Number: 870.3300
Classification Product Code: KRD
Date Received: 05/20/2015
Decision Date: 09/25/2015
Regulation Medical Specialty: Cardiovascular
Device Name: AZUR CX Detachable 35 Coils
Manufacturer: Micro Vention, Inc.
Device Classification Name: Device, Vascular, For Promoting Embolization
Regulation Number: 870.3300
Classification Product Code: KRD
Date Received: 05/20/2015
Decision Date: 09/25/2015
Regulation Medical Specialty: Cardiovascular
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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