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The Tracker / October 2026 / K260168

510(k) cleared

Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14)

Skycade Med Corporation · Oct 16, 2026 · K260168

FDA cleared the Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) from Skycade Med Corporation on Oct 16, 2026 under K260168, a traditional 510(k). The device falls under product code DQX, Wire, Guide, Catheter, regulated at 21 CFR 870.1330 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jan 20, 2026. The decision came 269 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Skycade Med Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260168?

K260168 is the FDA 510(k) for Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14), submitted by Skycade Med Corporation. FDA's decision date was Oct 16, 2026, under product code DQX (Wire, Guide, Catheter).

Who makes the Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14)?

Skycade Med Corporation, based in Dallas, TX, is the applicant of record for K260168.

How long did the K260168 review take?

FDA received the submission on Jan 20, 2026 and issued its decision on Oct 16, 2026, 269 days later.

← All decisions in October 2026