Cleared Traditional

K191717 - Route 92 Medical Sheath System

K191717 is an FDA 510(k) clearance for Route 92 Medical Sheath System, manufactured by Route 92 Medical, Inc.. The device is a Class 2 Neurology device with product code DQY cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K191717 · Route 92 Medical, Inc. · Neurology device
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Jan 2020
Decision
201d
Days
Class 2
Risk

K191717 is an FDA 510(k) clearance for the Route 92 Medical Sheath System. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Route 92 Medical, Inc. (San Mateo, US). The FDA issued a Cleared decision on January 13, 2020 after a review of 201 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 Route 92 Medical, Inc. devices

FDA 510(k) Submission Details - K191717

510(k) Number K191717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2019
Decision Date January 13, 2020
Days to Decision 201 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
53d slower than avg
Panel avg: 148d · This submission: 201d
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 619
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K191717.
Wingman 14, Wingman 14C, Wingman 18, Wingman 35
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K192135 · MicroVention, Inc. · Dec 2019
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K191551 · Rist Neurovascular, Inc. · Dec 2019