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FDA 510(k)

Gel-Bead

K-Number: K171946 · 2017-10-25

ApplicantVascular Solutions, Inc.
Decision Date2017-10-25
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Gel-Bead is a medical device manufactured by Vascular Solutions, Inc.. It received FDA 510(k) clearance on 2017-10-25 under approval number K171946. 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?

Gel-Bead is a medical device that received FDA 510(k) clearance on 2017-10-25. It is manufactured by Vascular Solutions, Inc.. The 510(k) number is K171946.

When was Gel-Bead approved by the FDA?

Gel-Bead received FDA 510(k) clearance on 2017-10-25, under approval number K171946.

What company makes Gel-Bead?

Gel-Bead is manufactured by Vascular Solutions, Inc..

What is the FDA product code for Gel-Bead?

The FDA product code for Gel-Bead is KRD.

Other Devices by Vascular Solutions, Inc.

K161702Endura guidewire K162272Fluent inflation device K161336VSI StraitSet micro-introducer kit K173532Raider Guidewire K173266Octane aspiration system K170544Langston dual lumen catheter

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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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