U.S. FDA Grants 510(k) Clearance for Impella Low Profile Sheath

Oct 17, 2022 | Industry Press Releases

The United States Food and Drug Administration (FDA) has granted 510(k) clearance to Abiomed (Nasdaq: ABMD) for its Impella Low Profile Sheath. Compared to the existing 14 French (Fr) sheath used for placement of Impella CP, the new sheath maintains the same inner diameter, but reduces the outer diameter by nearly 2 Fr.