Cleared Traditional

INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099) (K964021) - FDA 510(k) Clearance

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

K964021 · Baxter Edwards · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
171d
Days
Class 2
Risk

K964021 is an FDA 510(k) clearance for the INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099). Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by Baxter Edwards (Irvine, US). The FDA issued a Cleared decision on March 27, 1997 after a review of 171 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5950 - 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 Baxter Edwards devices

Submission Details

510(k) Number K964021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1996
Decision Date March 27, 1997
Days to Decision 171 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 148d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HCG Device, Neurovascular Embolization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5950
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 - HCG Device, Neurovascular Embolization

All 184
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K964021.
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K242154 · MicroPort NeuroTech (Shanghai) Co., Ltd. · Sep 2024