Cleared Traditional

Crosser iQ CTO Recanalization System

K203363 · C.R. Bard, Inc. · Cardiovascular

Aug 2021

Decision

269d

Days

Class 2

Risk

About This 510(k) Submission

K203363 is an FDA 510(k) clearance for the Crosser iQ CTO Recanalization System, a Catheter For Crossing Total Occlusions (Class II — Special Controls, product code PDU), submitted by C.R. Bard, Inc. (Tempe, US). The FDA issued a Cleared decision on August 12, 2021, 269 days after receiving the submission on November 16, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K203363 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 16, 2020
Decision Date	August 12, 2021
Days to Decision	269 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	PDU — Catheter For Crossing Total Occlusions
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1250
Definition	To Facilitate The Intraluminal Placement Of Conventional Guidewires Beyond Stenotic Lesions (including Subchronic And Chronic Total Occlusions) In The Peripheral Vasculature Prior To Further Percutaneous Intervention, Such As Angioplasty, Atherectomy Or Stent Placement.