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510(k) K141060

CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT by On-X Life Technologies, Inc. — Product Code PAW

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 6, 2014
Date Received: April 24, 2014
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement
Device Class: Class II
Regulation Number: 870.3470
Review Panel: CV
Submission Type

To repair or replace chordae tendinae.