Cleared Special

K173891 - Gel-Bead (600-800 micron) - 1 ml sphere...

K173891 is the FDA 510(k) clearance for Gel-Bead (600-800 micron) - 1 ml sphere... by Vascular Solutions, Inc.. It is a Class 2 Cardiovascular device (product code KRD) cleared through the Special 510(k) pathway after a 29-day FDA review.

K173891 · Vascular Solutions, Inc. · Cardiovascular device
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Jan 2018
Decision
29d
Days
Class 2
Risk

K173891 is an FDA 510(k) clearance for the Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2.... Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by Vascular Solutions, Inc. (Minneapolis, US). The FDA issued a Cleared decision on January 19, 2018 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Vascular Solutions, Inc. devices

Submission Details

510(k) Number K173891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2017
Decision Date January 19, 2018
Days to Decision 29 days
Submission Type Special
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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 97
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K173891.
EmboCube Embolization Gelatin
K181021 · Biosphere Medical, S.A. · Sep 2018
Embosphere Microspheres
K181300 · Biosphere Medical, S.A. · Jul 2018
IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm
K181051 · Shape Memory Medical · Jun 2018
Gel-Bead
K171946 · Vascular Solutions, Inc. · Oct 2017
AZUR CX Detachable 18 Peripheral Coil System
K162524 · MicroVention, Inc. · Mar 2017
Hilal Embolization MicroCoils
K160219 · Cook Incorporated · Aug 2016