FDA 510(k)

MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT

K-Number: K000659 · 2000-03-29

Decision Date2000-03-29

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2000-03-29 under 510(k) number K000659. 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 MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT?

MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT is a medical device that received FDA 510(k) clearance on 2000-03-29. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K000659.

When did MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT receive FDA 510(k) clearance?

MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT received FDA 510(k) clearance on 2000-03-29, under 510(k) number K000659.

Who is the listed applicant for MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT?

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

What is the FDA product code for MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT?

The FDA product code for MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT 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.