Cleared Traditional

INFINITI? Ambi Angiographic Catheter

K232573 · Cordis US Corp · Cardiovascular

Nov 2023

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K232573 is an FDA 510(k) clearance for the INFINITI? Ambi Angiographic Catheter, a Catheter, Intravascular, Diagnostic (Class II — Special Controls, product code DQO), submitted by Cordis US Corp (Miami Lakes, US). The FDA issued a Cleared decision on November 21, 2023, 88 days after receiving the submission on August 25, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number	K232573 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 25, 2023
Decision Date	November 21, 2023
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF