FDA 510(k)

AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETER

K-Number: K984627 · 1999-07-27

ApplicantArterial Vascular Engineering, Inc.

Decision Date1999-07-27

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Arterial Vascular Engineering, Inc.. It received FDA 510(k) clearance on 1999-07-27 under 510(k) number K984627. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETER?

AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETER is a medical device that received FDA 510(k) clearance on 1999-07-27. The listed applicant is Arterial Vascular Engineering, Inc.. The 510(k) number is K984627.

When did AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETER receive FDA 510(k) clearance?

AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETER received FDA 510(k) clearance on 1999-07-27, under 510(k) number K984627.

Who is the listed applicant for AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETER?

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

What is the FDA product code for AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETER?

The FDA product code for AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETER is DQO.

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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.