FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart D—Cardiovascular Prosthetic Devices
CFR Sub-Part
Subpart E—Cardiovascular Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
OCL
Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
2
Product Code
PAW
Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement
2
Product Code
K
14
1060
CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT
2
Cleared 510(K)
K
12
1173
CHORD-X EPTFE SUTURE
2
Cleared 510(K)
PZX
Left Atrial Appendage Clip, Implantable
2
Product Code
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Chemistry
Review Panel
Dental
Review Panel
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Gastroenterology and Urology
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Review Panel
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Review Panel
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Review Panel
Obstetrical and Gynecological
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Orthopedic
Review Panel
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Review Panel
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Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 29 August 2025 at 11:05 pm
CV
/
subpart-e—surgical-devices
/
PAW
/
K121173
View Source
CHORD-X EPTFE SUTURE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K121173
510(k) Type
Abbreviated
Applicant
ON-XLIFETECHNOLOGIES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/16/2012
Days to Decision
121 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart D—Cardiovascular Prosthetic Devices
Subpart E—Cardiovascular Surgical Devices
Subpart E—Surgical Devices
OCL
Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
PAW
Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement
K
14
1060
CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT
K
12
1173
CHORD-X EPTFE SUTURE
PZX
Left Atrial Appendage Clip, Implantable
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Therapeutic Devices
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
CV
/
subpart-e—surgical-devices
/
PAW
/
K121173
View Source
CHORD-X EPTFE SUTURE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K121173
510(k) Type
Abbreviated
Applicant
ON-XLIFETECHNOLOGIES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/16/2012
Days to Decision
121 days
Submission Type
Summary