INFINITI™ Ambi Angiographic Catheter

FDA 510(k) K232573 · Cordis US Corp

Substantially Equivalent

510(k) numberK232573

Submission

Device name
INFINITI™ Ambi Angiographic Catheter
Applicant
Cordis US Corp
Miami Lakes, FL, US
Received
August 25, 2023
Decision date
November 21, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DQO – Catheter, Intravascular, Diagnostic
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1200
Specialty
Cardiovascular

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Questions and answers

When was INFINITI™ Ambi Angiographic Catheter cleared by the FDA?

INFINITI™ Ambi Angiographic Catheter (K232573) received a 510(k) decision of Substantially Equivalent on November 21, 2023, 88 days after the submission was received.

What is the product code of K232573?

The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.