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510(k) K121173

Device
CHORD-X EPTFE SUTURE
Applicant
ON-XLIFETECHNOLOGIES
510(k) number
K121173
Product code
PAW  
Decision
Substantially Equivalent (SESE)
Decision date
2012-08-16
Date received
2012-04-17
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
Abbreviated
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
K141060CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENTOn-X Life Technologies, Inc.2014-06-06

Legacy Summary#

summary

FDA Review#

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