Cleared Traditional

K260751 - 35 Helix Guidewire

K260751 is an FDA 510(k) clearance for 35 Helix Guidewire, manufactured by Piraeus Medical, Inc.. The device is a Class 2 Neurology device with product code MOF cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K260751 · Piraeus Medical, Inc. · Neurology device
Download Printable Device Report (PDF)
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Aug 2026
Decision
174d
Days
Class 2
Risk

K260751 is an FDA 510(k) clearance for the 35 Helix Guidewire. Classified as Guide, Wire, Catheter, Neurovasculature (product code MOF), Class II - Special Controls.

Submitted by Piraeus Medical, Inc. (Maple Grove, US). The FDA issued a Cleared decision on August 27, 2026 after a review of 174 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1330 - the FDA neurology device 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Piraeus Medical, Inc. devices

FDA 510(k) Submission Details - K260751

510(k) Number K260751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2026
Decision Date August 27, 2026
Days to Decision 174 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 148d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MOF Device Classification - Class 2, Special Controls

Product Code MOF Guide, Wire, Catheter, Neurovasculature
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 Neurology devices follow this clearance model.

Regulatory Peers - MOF Guide, Wire, Catheter, Neurovasculature

All 43
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