Cleared Traditional

K243047 - Zoom 7X Catheter (FDA 510(k) Clearance)

Also includes:
Zoom Aspiration Tubing Zoom POD Aspiration Tubing

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

K243047 · Imperative Care, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
243d
Days
Class 2
Risk

K243047 is an FDA 510(k) clearance for the Zoom 7X Catheter. Classified as Catheter, Thrombus Retriever (product code NRY), Class II - Special Controls.

Submitted by Imperative Care, Inc. (Campbell, US). The FDA issued a Cleared decision on May 28, 2025 after a review of 243 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 Imperative Care, Inc. devices

Submission Details

510(k) Number K243047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2024
Decision Date May 28, 2025
Days to Decision 243 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
95d slower than avg
Panel avg: 148d · This submission: 243d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NRY Catheter, Thrombus Retriever
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition The Device Is Intended To Restore Blood Flow By Removing Thrombus/clots In Patients Experiencing Ischemic Stroke. The Prior Clearances In This Category Have Been Limited To Simply Identifying Catheter Placed In The Peripheral, Coronary, And Neurovasculature. It Is Felt That This Is A Unique Claim And Should Not Be Combined With Previously Cleared Catheters Under A General Procode.
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 - NRY Catheter, Thrombus Retriever

All 105
Devices cleared under the same product code (NRY) and FDA review panel - the closest regulatory comparables to K243047.
Millipede System
K253590 · Perfuze, Ltd. · Mar 2026
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K253062 · Rapid Medical , Ltd. · Mar 2026
Esperance pHLO Aspiration System
K251357 · Phenox, Ltd. · Jan 2026
NeVasc Aspiration System
K251006 · Vesalio, Inc. · Nov 2025
Zoom System (Zoom 4S Catheter)
K252046 · Imperative Care, Inc. · Oct 2025
Tigertriever 17 Ultra Revascularization Device
K251603 · Rapid Medical , Ltd. · Oct 2025