Cleared Traditional

K053548 - MODIFIED PVA-PLUS FOAM EMBOLIZATION PARTICLES AND MAXISTAT AND MICROSTAT PVA FOAM EMBOLIZATION PARTICLES

K053548 is an FDA 510(k) clearance for MODIFIED PVA-PLUS FOAM EMBOLIZATION PAR..., manufactured by Protein Polymer Technologies, Inc.. The device is a Class 2 Neurology device with product code HCG cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K053548 · Protein Polymer Technologies, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
41d
Days
Class 2
Risk

K053548 is an FDA 510(k) clearance for the MODIFIED PVA-PLUS FOAM EMBOLIZATION PARTICLES AND MAXISTAT AND MICROSTAT PVA .... Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by Protein Polymer Technologies, Inc. (San Diego, US). The FDA issued a Cleared decision on January 30, 2006 after a review of 41 days - a notably fast clearance 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: 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 Protein Polymer Technologies, Inc. devices

FDA 510(k) Submission Details - K053548

510(k) Number K053548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2005
Decision Date January 30, 2006
Days to Decision 41 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
107d faster than avg
Panel avg: 148d · This submission: 41d
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 160
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K053548.
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
TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION
K053197 · Cordis Neurovascular, Inc. · Dec 2005
MICRUS MODIFIED MICROCOIL 18-SYSTEM, CERECYTE, MODEL CSP & CHE
K053160 · Micrus Endovascular Corporation · Dec 2005
MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES)
K050954 · MicroVention, Inc. · Jun 2005