FDA 510(k)

Gel-Bead

K-Number: K171946 · 2017-10-25

Decision Date2017-10-25

Product CodeKRD

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Gel-Bead is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Solutions, Inc.. It received FDA 510(k) clearance on 2017-10-25 under 510(k) 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. The listed applicant is Vascular Solutions, Inc.. The 510(k) number is K171946.

When did Gel-Bead receive FDA 510(k) clearance?

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

Who is the listed applicant for Gel-Bead?

The FDA 510(k) record lists Vascular Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gel-Bead?

The FDA product code for Gel-Bead is KRD.

Other records listing Vascular Solutions, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: KRD)

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Official Source

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