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FDA 510(k)

CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER

K-Number: K984214 · 1999-08-10

ApplicantCordis Neurovascular, Inc.
Decision Date1999-08-10
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER 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 1999-08-10 under 510(k) number K984214. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER?

CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 1999-08-10. The listed applicant is Cordis Neurovascular, Inc.. The 510(k) number is K984214.

When did CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER receive FDA 510(k) clearance?

CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER received FDA 510(k) clearance on 1999-08-10, under 510(k) number K984214.

Who is the listed applicant for CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER?

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 CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER?

The FDA product code for CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER is DXC.

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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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