FDA 510(k)

IMPRESS ANGIOGRAPHIC CATHETER WITH HYDROPHILIC COATING

K-Number: K093004 · 2010-02-12

Decision Date2010-02-12

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

IMPRESS ANGIOGRAPHIC CATHETER WITH HYDROPHILIC COATING 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 2010-02-12 under 510(k) number K093004. 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 IMPRESS ANGIOGRAPHIC CATHETER WITH HYDROPHILIC COATING?

IMPRESS ANGIOGRAPHIC CATHETER WITH HYDROPHILIC COATING is a medical device that received FDA 510(k) clearance on 2010-02-12. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K093004.

When did IMPRESS ANGIOGRAPHIC CATHETER WITH HYDROPHILIC COATING receive FDA 510(k) clearance?

IMPRESS ANGIOGRAPHIC CATHETER WITH HYDROPHILIC COATING received FDA 510(k) clearance on 2010-02-12, under 510(k) number K093004.

Who is the listed applicant for IMPRESS ANGIOGRAPHIC CATHETER WITH HYDROPHILIC COATING?

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 IMPRESS ANGIOGRAPHIC CATHETER WITH HYDROPHILIC COATING?

The FDA product code for IMPRESS ANGIOGRAPHIC CATHETER WITH HYDROPHILIC COATING 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.