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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K223545

APRO 70 Catheter and Alembic Aspiration Tubing · Alembic, LLC · decided 2023-02-17 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
APRO 70 CatheterAPRO-70-135Alembic, LLCNRY00850014025014
Alembic Aspiration TubingFG-01001Alembic, LLCNRY00850014025007
APRO 70 CatheterAPRO-70-132Alembic, LLCNRY00850014025038
APRO 70 CatheterFG-01016-N32Alembic, LLCNRY00850014025069