• FDA DYMISTA NDA 202236 approval records — 22 FDA documents, 848 pages
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FDA 510(k) K151313, ZelanteDVT Thrombectomy Set, by Boston Scientific Corporation

FDA 510(k) K151313, ZelanteDVT Thrombectomy Set, by Boston Scientific Corporation

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510(K) Number: K151313
Device Name: ZelanteDVT Thrombectomy Set
Manufacturer: Boston Scientific Corporation
Device Classification Name: peripheral mechanical thrombectomy with aspiration
Regulation Number: 870.5150
Classification Product Code: QEW
Date Received: 05/18/2015
Decision Date: 09/21/2015
Regulation Medical Specialty: Cardiovascular

Total pages: 983
Fully redacted pages: 761
Content pages: 222
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