CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT— 510(k) K141060

Substantially Equivalent

On-X Life Technologies, Inc.

FDA 510(k) clearance K141060 for CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT, Substantially Equivalent on 2014-06-06. Applicant: On-X Life Technologies, Inc..

Clearance details

Applicant
On-X Life Technologies, Inc.
Product code
Code PAW
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Austin, TX, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.