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U.S. Department of Health and Human Services

MAUDE - Manufacturer and User Facility Device Experience

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510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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114 records meeting your search criteria returned- Product Code: MCW Patient Problem: Perforation of Vessels Report Date From: 01/1/2017
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ManufacturerBrand NameDate Report Received
CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHER 05/30/2019
BOSTON SCIENTIFIC CORPORATION JETSTREAM XC 05/03/2019
CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHER 04/02/2019
MEDTRONIC IRELAND BTK TURBOHAWK 03/05/2019
MEDTRONIC IRELAND SILVERHAWK BTK 03/05/2019
CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHER 01/18/2019
BOSTON SCIENTIFIC CORPORATION PERIPHERAL ROTALINK PLUS 01/02/2019
CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHER 12/11/2018
BOSTON SCIENTIFIC CORPORATION JETSTREAM XC ATHERECTOMY CATHETER 11/14/2018
CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHER 11/14/2018
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