Class Class II

Sapphire ULTRA Coronary Dilatation Catheter (K233505)

K233505 2024-08-15 Traditional
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Description

Sapphire ULTRA Coronary Dilatation Catheter by OrbusNeich Medical (Shenzhen) Co., Ltd. — FDA 510(k) cleared cardiovascular device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK233505
Clearance Date2024-08-15
Clearance TypeTraditional
Product CodeLOX
Regulation Number870.5100

Categories

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