Cleared Traditional

INFINITI™ Ambi Angiographic Catheter (K232573) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K232573 · Cordis US Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2023
Decision
88d
Days
Class 2
Risk

K232573 is an FDA 510(k) clearance for the INFINITI™ Ambi Angiographic Catheter. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Cordis US Corp (Miami Lakes, US). The FDA issued a Cleared decision on November 21, 2023 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cordis US Corp devices

Submission Details

510(k) Number K232573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 125d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQO Catheter, Intravascular, Diagnostic

All 155
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K232573.
Impress Angiographic Catheter
K233268 · Merit Medical Systems, Inc. · May 2024
Zoom 6F Insert Catheters
K233975 · Imperative Care, Inc. · Apr 2024
Soldier Microcatheter
K232536 · Embolx, Inc. · Feb 2024
Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter
K230620 · Gentuity, LLC · Aug 2023
Drakon™ and Sequre® Microcatheters
K231293 · Accurate Medical Therapeutics · Jun 2023
Dragonfly OpStar™ Imaging Catheter
K230411 · Abbott Medical · Apr 2023