Cleared Traditional

TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform (K203764) - FDA 510(k) Clearance

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

K203764 · Imperative Care, Inc. · Neurology device
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Mar 2021
Decision
70d
Days
Class 2
Risk

K203764 is an FDA 510(k) clearance for the TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Larg.... Classified as Catheter, Percutaneous, Neurovasculature (product code QJP), Class II - Special Controls.

Submitted by Imperative Care, Inc. (Campbell, US). The FDA issued a Cleared decision on March 3, 2021 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Imperative Care, Inc. devices

Submission Details

510(k) Number K203764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2020
Decision Date March 03, 2021
Days to Decision 70 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
78d faster than avg
Panel avg: 148d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QJP Catheter, Percutaneous, Neurovasculature
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition To Provide Vascular Access To The Neurovasculature For Interventional Or Diagnostic Procedures
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 - QJP Catheter, Percutaneous, Neurovasculature

All 90
Devices cleared under the same product code (QJP) and FDA review panel - the closest regulatory comparables to K203764.
Balloon Guiding Catheter
K202916 · Shanghai Heartcare Medical Technology Co., Ltd. · Aug 2021
SelectFlex Neurovascular Access System Family
K211893 · Q'Apel Medical, Inc. · Aug 2021
Route 92 Medical Full Length 088 Access System
K210635 · Route 92 Medical, Inc. · Jul 2021
BOSS 8F Balloon Guide Catheter
K203840 · Marblehead Medical, LLC · Jan 2021
Route 92 Medical 070 Access System
K203043 · Route 92 Medical, Inc. · Nov 2020
RIST Radial Access Catheter
K201682 · Rist Neurovascular, Inc. · Sep 2020