FDA 510(k), K170059, Spectranetics Turbo-Elite Laser Atherectomy Catheters

FDA 510(k), K170059, Spectranetics Turbo-Elite Laser Atherectomy Catheters

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510(K) Number: K170059
Device Name: Spectranetics Turbo-Elite Laser Atherectomy Catheters
Manufacturer: Spectranetics, Inc.
Device Classification Name: catheter, peripheral, atherectomy
Regulation Number: 870.4875
Classification Product Code: MCW
Date Received: 01/06/2017
Decision Date: 04/07/2017
Regulation Medical Specialty: Cardiovascular

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