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FDA 510(k)

CHORD-X EPTFE SUTURE

K-Number: K121173 · 2012-08-16

ApplicantOn-Xlifetechnologies
Decision Date2012-08-16
Product CodePAW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CHORD-X EPTFE SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is On-Xlifetechnologies. It received FDA 510(k) clearance on 2012-08-16 under 510(k) number K121173. The device is classified under product code PAW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHORD-X EPTFE SUTURE?

CHORD-X EPTFE SUTURE is a medical device that received FDA 510(k) clearance on 2012-08-16. The listed applicant is On-Xlifetechnologies. The 510(k) number is K121173.

When did CHORD-X EPTFE SUTURE receive FDA 510(k) clearance?

CHORD-X EPTFE SUTURE received FDA 510(k) clearance on 2012-08-16, under 510(k) number K121173.

Who is the listed applicant for CHORD-X EPTFE SUTURE?

The FDA 510(k) record lists On-Xlifetechnologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHORD-X EPTFE SUTURE?

The FDA product code for CHORD-X EPTFE SUTURE is PAW.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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