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FDA 510(k)

Impress Angiographic Catheter

K-Number: K191608 · 2019-07-16

ApplicantMerit Medical Systems, Inc.
Decision Date2019-07-16
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Impress Angiographic Catheter is a medical device manufactured by Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2019-07-16 under approval number K191608. 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 2019-07-16. It is manufactured by Merit Medical Systems, Inc.. The 510(k) number is K191608.

When was Impress Angiographic Catheter approved by the FDA?

Impress Angiographic Catheter received FDA 510(k) clearance on 2019-07-16, under approval number K191608.

What company makes Impress Angiographic Catheter?

Impress Angiographic Catheter is manufactured by Merit Medical Systems, Inc..

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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