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FDA 510(k) K143541, Relieva SpinPlus Balloon Sinuplasty System, by Acclarent, Inc.

FDA 510(k) K143541, Relieva SpinPlus Balloon Sinuplasty System, by Acclarent, Inc.

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510(K) Number: K143541
Device Name: Relieva SpinPlus Balloon Sinuplasty System
Manufacturer: Acclarent, Inc.
Device Classification Name: instrument, ent manual surgical
Regulation Number: 874.4420
Classification Product Code: LRC
Date Received: 12/15/2014
Decision Date: 04/22/2015
Regulation Medical Specialty: Ear Nose & Throat
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