FDA applicant

Scion Cardio-Vascular, Inc.

Miami, FL4 decisions2004–20110 recalls

FDA records 4 decisions for Scion Cardio-Vascular, Inc. (Miami, FL) from 2004 to 2011: 4 510(k) clearances. Most are in product codes QSY (Hemostatic Wound Dressing Without Thrombin Or…) and HCG (Device, Neurovascular Embolization). Its devices cite 6 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Scion Cardio-Vascular, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Scion Cardio-Vascular, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Scion Cardio-Vascular, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Scion”

FDA records each applicant name separately; these may or may not be the same firm.

Scion Medical Technologies, LLC 6 Scion International, Inc. 4 Scion Cardiovascular, Inc. 1 Scion Valley, Inc. 1 Scion Neurostim, LLC 1

Scion Cardio-Vascular, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Scion”