FDA 510(k)

CVIS INSIGHT IMAGING GUIDE CATHETER

K-Number: K930232 · 1993-07-21

ApplicantCardiovascular Imaging Systems, Inc.

Decision Date1993-07-21

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CVIS INSIGHT IMAGING GUIDE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Cardiovascular Imaging Systems, Inc.. It received FDA 510(k) clearance on 1993-07-21 under 510(k) number K930232. 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 CVIS INSIGHT IMAGING GUIDE CATHETER?

CVIS INSIGHT IMAGING GUIDE CATHETER is a medical device that received FDA 510(k) clearance on 1993-07-21. The listed applicant is Cardiovascular Imaging Systems, Inc.. The 510(k) number is K930232.

When did CVIS INSIGHT IMAGING GUIDE CATHETER receive FDA 510(k) clearance?

CVIS INSIGHT IMAGING GUIDE CATHETER received FDA 510(k) clearance on 1993-07-21, under 510(k) number K930232.

Who is the listed applicant for CVIS INSIGHT IMAGING GUIDE CATHETER?

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

What is the FDA product code for CVIS INSIGHT IMAGING GUIDE CATHETER?

The FDA product code for CVIS INSIGHT IMAGING GUIDE CATHETER is DQO.

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Other records listing Cardiovascular Imaging Systems, Inc. as applicant

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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.