510(k) K082143

MICRO GUIDE CATHETER XP by Cordis Corp. — Product Code PDU

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 25, 2008
Date Received: July 30, 2008
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Catheter For Crossing Total Occlusions
Device Class: Class II
Regulation Number: 870.1250
Review Panel: CV
Submission Type

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.

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