Cleared Traditional

K061790 - PVA PLUS, MAXISTAT PVA, MICROSTAT PVA FOAM EMBOLIZATION PARTICLES

K061790 is an FDA 510(k) clearance for PVA PLUS, manufactured by Protein Polymer Technologies, Inc.. The device is a Class 2 Neurology device with product code KRD cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K061790 · Protein Polymer Technologies, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
85d
Days
Class 2
Risk

K061790 is an FDA 510(k) clearance for the PVA PLUS, MAXISTAT PVA, MICROSTAT PVA FOAM EMBOLIZATION PARTICLES. Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by Protein Polymer Technologies, Inc. (San Diego, US). The FDA issued a Cleared decision on September 19, 2006 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.3300 - 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.

FDA 510(k) Submission Details - K061790

510(k) Number K061790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2006
Decision Date September 19, 2006
Days to Decision 85 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
64d faster than avg
Panel avg: 149d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRD Device Classification - Class 2, Special Controls

Product Code KRD Device, Vascular, For Promoting Embolization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3300
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 - KRD Device, Vascular, For Promoting Embolization

All 130
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K061790.
AMPLATZER VASCULAR PLUG II MODELS: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, AVP2-016
K071125 · Aga Medical Corp. · Jun 2007
FLIPPER DETACHABLE EMBOLIZATION COILS
K063619 · Cook, Inc. · Dec 2006
HEPASPHERE MICROSPHERES
K052742 · Biosphere Medical, Inc. · Nov 2006
FIBERED IDC OCCLUSION SYSTEM
K060078 · Boston Scientific Corporation · Jan 2006
MREYE EMBOLIZATION COIL
K052834 · Cook, Inc. · Nov 2005
CONCENTRIC EMBOLIC PEARLS
K050470 · Concentric Medical, Inc. · May 2005
K061790 · PVA PLUS, MAXISTAT PVA, MICROSTAT PVA FOAM EMBOLIZATION PARTICLES
Download PDF FDA Summary Protein Polymer Techn…