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510(k) K141060

Device
CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT
Applicant
ON-X LIFE TECHNOLOGIES, INC.
510(k) number
K141060
Product code
PAW  
Decision
Substantially Equivalent (SESE)
Decision date
2014-06-06
Date received
2014-04-24
Regulation
878.5035
Classification name
Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement
Medical specialty
General & Plastic Surgery
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JOHN ELY
Address
1300 E. Anderson Ln. Bldg. B Austin TX US 78752 78752

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PAW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252126MitraPatch Mitral Valve Repair SystemChawla Heart Technologies, LLC2025-12-04
K121173CHORD-X EPTFE SUTUREOn-Xlifetechnologies2012-08-16

Legacy Summary#

summary

FDA Review#

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