Cleared Traditional

K073544 - PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA FOAM EMBOLIZATION PARTICLES

K073544 is an FDA 510(k) clearance for PVA PLUS VIAL PVA FOAM EMBOLIZATION PAR..., manufactured by Rj Medical, Inc.. The device is a Class 2 Cardiovascular device with product code KRD cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K073544 · Rj Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
78d
Days
Class 2
Risk

K073544 is an FDA 510(k) clearance for the PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA F.... Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by Rj Medical, Inc. (El Dorado Hills, US). The FDA issued a Cleared decision on March 5, 2008 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3300 - the FDA cardiovascular device oversight 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 - K073544

510(k) Number K073544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2007
Decision Date March 05, 2008
Days to Decision 78 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 125d · This submission: 78d
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 Cardiovascular 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 K073544.
LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES
K083091 · Biocompatibles UK Limited · Dec 2008
EMBOZENE MICROSPHERES
K073417 · Celonova Biosciences, Inc. · Dec 2008
AXIUM DETACHABLE COIL SYSTEM
K081465 · Micro Therapeutics, Inc. · Aug 2008
HYDROCOIL EMBOLIC SYSTEMS (HES)
K071939 · MicroVention, Inc. · Jan 2008
AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022
K071699 · Aga Medical Corp. · Aug 2007
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
K073544 · PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA FOAM EMBOLIZATION PARTICLES
Download PDF FDA Summary Rj Medical, Inc.