Epc Filter

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K813123 ↗

FDA Product Code

DRR

Device Class

Class II

Regulation

21 CFR Part 870.2050

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Codman & Shurtleff, Inc. →