Cleared Traditional

K260168 - Small Diameter Core Wire (CMAN-000-00)

Also marketed or referenced as:
Small Diameter Core Wire (CMAN-000-14)

K260168 is an FDA 510(k) clearance for Small Diameter Core Wire (CMAN-000-00), manufactured by Skycade Med Corporation. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K260168 · Skycade Med Corporation · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
269d
Days
Class 2
Risk

K260168 is an FDA 510(k) clearance for the Small Diameter Core Wire (CMAN-000-00). Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Skycade Med Corporation (Dallas, US). The FDA issued a Cleared decision on October 16, 2026 after a review of 269 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K260168

510(k) Number K260168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2026
Decision Date October 16, 2026
Days to Decision 269 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 125d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQX Device Classification - Class 2, Special Controls

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQX Wire, Guide, Catheter

All 768
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K260168.
Hyperdrive 35 Guidewire
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Merit MAK Nitinol/Gold-Tungsten Guide Wire
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InQwire Amplatz Guide Wire
K254137 · Merit Medical Ireland, Ltd. · May 2026
FMD Peripheral Guide Wire F-14 Flex 6
K260544 · FMD Co., Ltd. · Mar 2026
K260168 · Small Diameter Core Wire (CMAN-000-00)
Download PDF FDA Summary Skycade Med Corporati…