Cleared Traditional

Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter (K192558) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192558 · Mivi Neurovascular · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2020
Decision
202d
Days
Class 2
Risk

K192558 is an FDA 510(k) clearance for the Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Cathet.... Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Mivi Neurovascular (Eden Prarie, US). The FDA issued a Cleared decision on April 6, 2020 after a review of 202 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 Mivi Neurovascular devices

Submission Details

510(k) Number K192558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2019
Decision Date April 06, 2020
Days to Decision 202 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
54d slower than avg
Panel avg: 148d · This submission: 202d
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 888
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K192558.
Perfect-O Ostial Positioning Catheter
K260289 · Balosmark, Inc. · Jun 2026
Amplatzer TorqVue Delivery System
K260993 · Abbott · Apr 2026
Teleport Glide Microcatheter
K253361 · OrbusNeich Medical (Shenzhen) Co., Ltd. · Apr 2026
Amplatzer™ Trevisio™ Intravascular Delivery System
K260499 · Abbott Medical · Mar 2026
C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)
K253409 · Medtronic, Inc. · Dec 2025
Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)
K252417 · Abbott Medical · Dec 2025