Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14)— 510(k) K260168

Name: FDA 510(k) clearance K260168
Creator: U.S. Food and Drug Administration
Published: 2026-10-16

Substantially Equivalent

Skycade Med Corporation

FDA 510(k) clearance K260168 for Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14), Substantially Equivalent on 2026-10-16. Applicant: Skycade Med Corporation. Device class: 2.

Clearance details

Applicant: Skycade Med Corporation
Product code: Product code DQX
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 2026-01-20
Decision date: 2026-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DQX

view all

K253146 — Hyperdrive 35 Guidewire2026-09-18
K261281 — CROSSLEAD Standard 035 and CROSSLEAD Stiff 0352026-09-03
K253667 — Accoat Guide Wire2026-07-14
K261640 — Merit MAK Nitinol/Gold-Tungsten Guide Wire2026-07-13
K254137 — InQwire Amplatz Guide Wire2026-05-22

Adverse events under product code DQX

product code DQX

Death: 298
Injury: 4,385
Malfunction: 7,203
Other: 5
Total: 11,891

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.