Cleared Abbreviated

K052509 - M-BOLUS EMBOLIC MICROSPHERES

K052509 is an FDA 510(k) clearance for M-BOLUS EMBOLIC MICROSPHERES, manufactured by Scion Cardio-Vascular, Inc.. The device is a Class 2 Neurology device with product code HCG cleared through the Abbreviated 510(k) pathway after a 454-day FDA review.

K052509 · Scion Cardio-Vascular, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
454d
Days
Class 2
Risk

K052509 is an FDA 510(k) clearance for the M-BOLUS EMBOLIC MICROSPHERES. Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by Scion Cardio-Vascular, Inc. (Miami, US). The FDA issued a Cleared decision on December 11, 2006 after a review of 454 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5950 - the FDA neurology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. Standards-verified equivalence. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Scion Cardio-Vascular, Inc. devices

FDA 510(k) Submission Details - K052509

510(k) Number K052509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2005
Decision Date December 11, 2006
Days to Decision 454 days
Submission Type Abbreviated
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
306d slower than avg
Panel avg: 148d · This submission: 454d
Pathway characteristics
Standards-based clearance path.

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 157
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K052509.
FX DETACHABLE COIL SYSTEM
K060747 · Micro Therapeutics, Inc. · Apr 2007
MICRUS MICROCOIL SYSTEM
K070707 · Micrus Endovascular Corporation · Apr 2007
MICRUS MICROCOIL SYSTEM, CASHMERE MODEL SRC
K063653 · Micrus Endovascular Corporation · Jan 2007
THE TRUFILL DCS DETACHABLE COIL SYSTEM
K063254 · Cordis Neurovascular, Inc. · Dec 2006
MICRUS MICROCOIL SYSTEM PRESIDIO-18, MODEL PC4
K062036 · Micrus Endovascular Corporation · Aug 2006
NEXUS DETACHABLE COIL SYSTEM, MORPHEUS 3D CSR
K060625 · Micro Therapeutics, Inc. · Apr 2006