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FDA 510(k)

GEL-BLOCK EMBOLIZATION PLEDGETS

K-Number: K113266 · 2012-05-14

ApplicantVascular Solutions, Inc.
Decision Date2012-05-14
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GEL-BLOCK EMBOLIZATION PLEDGETS 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 2012-05-14 under 510(k) number K113266. 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-BLOCK EMBOLIZATION PLEDGETS?

GEL-BLOCK EMBOLIZATION PLEDGETS is a medical device that received FDA 510(k) clearance on 2012-05-14. The listed applicant is Vascular Solutions, Inc.. The 510(k) number is K113266.

When did GEL-BLOCK EMBOLIZATION PLEDGETS receive FDA 510(k) clearance?

GEL-BLOCK EMBOLIZATION PLEDGETS received FDA 510(k) clearance on 2012-05-14, under 510(k) number K113266.

Who is the listed applicant for GEL-BLOCK EMBOLIZATION PLEDGETS?

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-BLOCK EMBOLIZATION PLEDGETS?

The FDA product code for GEL-BLOCK EMBOLIZATION PLEDGETS is KRD.

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Other records listing Vascular Solutions, Inc. as applicant

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Related Devices (Code: KRD)

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.

K252812UniPearls® Embolic MicrospheresSuzhou Haowei Medical Technology Co., Ltd.K261488OBSIDIO Conformable EmbolicBoston Scientific CorporationK261866Concerto Versa™ Detachable CoilMedtronic, Inc.K260635HARBOR Occlusion DeviceNuvascular, Inc.K260508LOBO Vascular Occlusion SystemOkami Medical, Inc.K253511Concerto Versa™ Detachable CoilMedtronic, Inc.

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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