Cleared Traditional

K200374 - Columbus Guidewire

K200374 is the FDA 510(k) clearance for Columbus Guidewire by Rapid Medical , Ltd.. It is a Class 2 Neurology device (product code MOF) cleared through the Traditional 510(k) pathway after a 304-day FDA review.

K200374 · Rapid Medical , Ltd. · Neurology device
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Dec 2020
Decision
304d
Days
Class 2
Risk

K200374 is an FDA 510(k) clearance for the Columbus Guidewire. Classified as Guide, Wire, Catheter, Neurovasculature (product code MOF), Class II - Special Controls.

Submitted by Rapid Medical , Ltd. (Yokneam, IL). The FDA issued a Cleared decision on December 14, 2020 after a review of 304 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Rapid Medical , Ltd. devices

Submission Details

510(k) Number K200374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2020
Decision Date December 14, 2020
Days to Decision 304 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
156d slower than avg
Panel avg: 148d · This submission: 304d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Hogan Lovells US LLP
Janice Hogan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MOF Guide, Wire, Catheter, Neurovasculature

All 38
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