FDA 510(k)

CES VASCULAR OCCLUSION SYSTEM

K-Number: K964367 · 1997-01-30

Decision Date1997-01-30

Product CodeHCG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

CES VASCULAR OCCLUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Neurovascular, Inc.. It received FDA 510(k) clearance on 1997-01-30 under 510(k) number K964367. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CES VASCULAR OCCLUSION SYSTEM?

CES VASCULAR OCCLUSION SYSTEM is a medical device that received FDA 510(k) clearance on 1997-01-30. The listed applicant is Cordis Neurovascular, Inc.. The 510(k) number is K964367.

When did CES VASCULAR OCCLUSION SYSTEM receive FDA 510(k) clearance?

CES VASCULAR OCCLUSION SYSTEM received FDA 510(k) clearance on 1997-01-30, under 510(k) number K964367.

Who is the listed applicant for CES VASCULAR OCCLUSION SYSTEM?

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

What is the FDA product code for CES VASCULAR OCCLUSION SYSTEM?

The FDA product code for CES VASCULAR OCCLUSION SYSTEM is HCG.

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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.