Cleared Traditional

K964021 - INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099)

K964021 is an FDA 510(k) clearance for INTRAMED SIDE BRANCH OCCLUSION (SBO) SY..., manufactured by Baxter Edwards. The device is a Class 2 Neurology device with product code HCG cleared through the Traditional 510(k) pathway after a 171-day FDA review.

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

FDA 510(k) Submission Details - K964021

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.

HCG Device Classification - Class 2, Special Controls

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 159
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K964021.
GUGLIELMI DETACHABLE (GDC)
K991139 · Boston Scientific, Target · Dec 1999
VASCULAR OCCLUSION SYSTEM
K983483 · Cordis Neurovascular, Inc. · Mar 1999
CES VASCULAR OCCLUSION SYSTEM
K972881 · Cordis Neurovascular, Inc. · Jun 1998
TRUFILL PVA PARTICLES
K965174 · Cordis Neurovascular, Inc. · Mar 1997
CES VASCULAR OCCLUSION SYSTEM
K964367 · Cordis Neurovascular, Inc. · Jan 1997
GDC PATIENT RETURN ELECTTRODE MODEL 45021
K963307 · Target Therapeutics · Dec 1996