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FDA 510(k)

Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume

K-Number: K173891 · 2018-01-19

ApplicantVascular Solutions, Inc.
Decision Date2018-01-19
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume is a medical device manufactured by Vascular Solutions, Inc.. It received FDA 510(k) clearance on 2018-01-19 under approval number K173891. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume?

Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume is a medical device that received FDA 510(k) clearance on 2018-01-19. It is manufactured by Vascular Solutions, Inc.. The 510(k) number is K173891.

When was Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume approved by the FDA?

Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume received FDA 510(k) clearance on 2018-01-19, under approval number K173891.

What company makes Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume?

Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume is manufactured by Vascular Solutions, Inc..

What is the FDA product code for Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume?

The FDA product code for Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume is KRD.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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