Cleared Traditional

K182487 - CerusEndo Microcatheter

K182487 is an FDA 510(k) clearance for CerusEndo Microcatheter, manufactured by Cerus Endovascular, Inc.. The device is a Class 2 Neurology device with product code DQY cleared through the Traditional 510(k) pathway after a 312-day FDA review.

K182487 · Cerus Endovascular, Inc. · Neurology device
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Jul 2019
Decision
312d
Days
Class 2
Risk

K182487 is an FDA 510(k) clearance for the CerusEndo Microcatheter. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Cerus Endovascular, Inc. (Fremont, US). The FDA issued a Cleared decision on July 20, 2019 after a review of 312 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1250 - 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 Cerus Endovascular, Inc. devices

FDA 510(k) Submission Details - K182487

510(k) Number K182487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2018
Decision Date July 20, 2019
Days to Decision 312 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
164d slower than avg
Panel avg: 148d · This submission: 312d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 621
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K182487.
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K190475 · Centerpoint Systems · Jun 2019