510(k) Report

FDA applicant

Skycade Med Corporation

Dallas, TX1 decision2026–20260 recalls

FDA records 1 decision for Skycade Med Corporation (Dallas, TX) in 2026: 1 510(k) clearance. All are in product code DQX (Wire, Guide, Catheter). 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, cardiovascular panel, where it files most

How often FDA has decided Skycade Med Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2026

2026 (partial year): 1
2026high 1 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

FIG. 1 — Skycade Med Corporation by year, 2026–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DQXWire, Guide, Catheter1decision

What has FDA decided for it lately?

  • K260168Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14)Skycade Med Corporation · 2026

The one decision as Skycade Med Corporation →