Cleared Traditional

K182602 - SOFIA EX Intracranial Support Catheter

K182602 is an FDA 510(k) clearance for SOFIA EX Intracranial Support Catheter, manufactured by MicroVention, Inc.. The device is a Class 2 Neurology device with product code DQY cleared through the Traditional 510(k) pathway after a 236-day FDA review.

K182602 · MicroVention, Inc. · Neurology device
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May 2019
Decision
236d
Days
Class 2
Risk

K182602 is an FDA 510(k) clearance for the SOFIA EX Intracranial Support Catheter. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by MicroVention, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on May 15, 2019 after a review of 236 days - an extended review cycle.

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. 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 MicroVention, Inc. devices

FDA 510(k) Submission Details - K182602

510(k) Number K182602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2018
Decision Date May 15, 2019
Days to Decision 236 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
88d slower than avg
Panel avg: 148d · This submission: 236d
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 780
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