Cleared Special

K191664 - SelectFlex 072 Neurovascular Access System

K191664 is the FDA 510(k) clearance for SelectFlex 072 Neurovascular Access System by Q'Apel Medical. It is a Class 2 Neurology device (product code DQY) cleared through the Special 510(k) pathway after a 70-day FDA review.

K191664 · Q'Apel Medical · Neurology device
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Aug 2019
Decision
70d
Days
Class 2
Risk

K191664 is an FDA 510(k) clearance for the SelectFlex 072 Neurovascular Access System. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Q'Apel Medical (Santa Monica, US). The FDA issued a Cleared decision on August 30, 2019 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1250 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Q'Apel Medical devices

Submission Details

510(k) Number K191664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2019
Decision Date August 30, 2019
Days to Decision 70 days
Submission Type Special
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
78d faster than avg
Panel avg: 148d · This submission: 70d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

Lakeshore Medical Device Consulting, LLC
Michele Lucey

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 - DQY Catheter, Percutaneous

All 573
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