FDA 510(k)

INFINITI™ Ambi Angiographic Catheter

K-Number: K232573 · 2023-11-21

Decision Date2023-11-21

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

INFINITI™ Ambi Angiographic Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Cordis US Corp. It received FDA 510(k) clearance on 2023-11-21 under 510(k) number K232573. 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 INFINITI™ Ambi Angiographic Catheter?

INFINITI™ Ambi Angiographic Catheter is a medical device that received FDA 510(k) clearance on 2023-11-21. The listed applicant is Cordis US Corp. The 510(k) number is K232573.

When did INFINITI™ Ambi Angiographic Catheter receive FDA 510(k) clearance?

INFINITI™ Ambi Angiographic Catheter received FDA 510(k) clearance on 2023-11-21, under 510(k) number K232573.

Who is the listed applicant for INFINITI™ Ambi Angiographic Catheter?

The FDA 510(k) record lists Cordis US Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INFINITI™ Ambi Angiographic Catheter?

The FDA product code for INFINITI™ Ambi Angiographic Catheter is DQO.

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Related Devices (Code: 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.