Class Class II

Tembo Embolic System (K253677)

K253677 2025-12-15 Special
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Description

Tembo Embolic System by Instylla, Inc., an FDA 510(k) cleared cardiovascular device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK253677
Clearance Date2025-12-15
Clearance TypeSpecial
Product CodeKRD
Regulation Number870.3300

Categories

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