Class Class II

Optima Coil System (Optima Packing Coil System) (K252700)

K252700 2025-09-26 Special
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Description

Optima Coil System (Optima Packing Coil System) by Balt USA, LLC, an FDA 510(k) cleared neurology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK252700
Clearance Date2025-09-26
Clearance TypeSpecial
Product CodeHCG
Regulation Number882.5950

Categories

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