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Introducer Kit for Impella®

Oscor Inc. · Model 0052-3006 · UDI-DI 00813502011609

DTD Prescription

510(k) clearances

741

Adverse events (40 deaths)

Recalls

Facilities

Description

Hemostatic Peel Away Introducer System with Infusion Sideport, 23F

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.