Cleared Traditional

K214024 - SOFIA 88 Catheter

K214024 is the FDA 510(k) clearance for SOFIA 88 Catheter by MicroVention, Inc.. It is a Class 2 Neurology device (product code DQY) cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K214024 · MicroVention, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2022
Decision
264d
Days
Class 2
Risk

K214024 is an FDA 510(k) clearance for the SOFIA 88 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 September 12, 2022 after a review of 264 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

Submission Details

510(k) Number K214024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2021
Decision Date September 12, 2022
Days to Decision 264 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
116d slower than avg
Panel avg: 148d · This submission: 264d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 573
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K214024.
Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system
K222873 · Medtronic · Nov 2022
Houdini Cross Support Catheter
K213466 · Cruzar Medsystems, Inc. · Oct 2022
Sublime Microcatheter
K221886 · Surmodics,Inc. · Oct 2022
GuideLiner Coast, 5.5F (5270)
K220647 · Vascular Solutions, LLC · Aug 2022
091 Balloon Guide Catheter
K220331 · Inneuroco, Inc. · Jul 2022
Selectra Lead Implantation System
K222037 · Biotronik, Inc. · Jul 2022