FDA 510(k)

Impress Angiographic Catheter

K-Number: K233268 · 2024-05-22

Decision Date2024-05-22

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Impress Angiographic Catheter 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 2024-05-22 under 510(k) number K233268. 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?

Impress Angiographic Catheter is a medical device that received FDA 510(k) clearance on 2024-05-22. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K233268.

When did Impress Angiographic Catheter receive FDA 510(k) clearance?

Impress Angiographic Catheter received FDA 510(k) clearance on 2024-05-22, under 510(k) number K233268.

Who is the listed applicant for Impress Angiographic Catheter?

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?

The FDA product code for Impress 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.