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FDA 510(k)

OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICE

K-Number: K093813 · 2010-05-10

ApplicantImbiotechnologies
Decision Date2010-05-10
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Imbiotechnologies. It received FDA 510(k) clearance on 2010-05-10 under 510(k) number K093813. 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 OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICE?

OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICE is a medical device that received FDA 510(k) clearance on 2010-05-10. The listed applicant is Imbiotechnologies. The 510(k) number is K093813.

When did OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICE receive FDA 510(k) clearance?

OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICE received FDA 510(k) clearance on 2010-05-10, under 510(k) number K093813.

Who is the listed applicant for OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICE?

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

What is the FDA product code for OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICE?

The FDA product code for OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICE is KRD.

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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.

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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.

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