FDA 510(k)

CVIS INSIGHT 15MHZ CATHETERS FOR PERIPHERAL USE

K-Number: K901691 · 1990-07-06

ApplicantCardiovascular Imaging Systems, Inc.

Decision Date1990-07-06

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CVIS INSIGHT 15MHZ CATHETERS FOR PERIPHERAL USE 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 1990-07-06 under 510(k) number K901691. 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 15MHZ CATHETERS FOR PERIPHERAL USE?

CVIS INSIGHT 15MHZ CATHETERS FOR PERIPHERAL USE is a medical device that received FDA 510(k) clearance on 1990-07-06. The listed applicant is Cardiovascular Imaging Systems, Inc.. The 510(k) number is K901691.

When did CVIS INSIGHT 15MHZ CATHETERS FOR PERIPHERAL USE receive FDA 510(k) clearance?

CVIS INSIGHT 15MHZ CATHETERS FOR PERIPHERAL USE received FDA 510(k) clearance on 1990-07-06, under 510(k) number K901691.

Who is the listed applicant for CVIS INSIGHT 15MHZ CATHETERS FOR PERIPHERAL USE?

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 15MHZ CATHETERS FOR PERIPHERAL USE?

The FDA product code for CVIS INSIGHT 15MHZ CATHETERS FOR PERIPHERAL USE 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.