Cleared Special

MICRO GUIDE CATHETER XP

K082143 · Cordis Corp. · Cardiovascular

Aug 2008

Decision

26d

Days

Class 2

Risk

About This 510(k) Submission

K082143 is an FDA 510(k) clearance for the MICRO GUIDE CATHETER XP, a Catheter For Crossing Total Occlusions (Class II — Special Controls, product code PDU), submitted by Cordis Corp. (Warren, US). The FDA issued a Cleared decision on August 25, 2008, 26 days after receiving the submission on July 30, 2008. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K082143 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 30, 2008
Decision Date	August 25, 2008
Days to Decision	26 days
Submission Type	Special
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.