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FDA 510(k)

Ventix Link Knotless Anchor with Inserter

K-Number: K180274 · 2018-03-21

Decision Date2018-03-21
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Ventix Link Knotless Anchor with Inserter is the device name listed in this FDA 510(k) record. The listed applicant is Cayenne Medical, Inc.. It received FDA 510(k) clearance on 2018-03-21 under 510(k) number K180274. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ventix Link Knotless Anchor with Inserter?

Ventix Link Knotless Anchor with Inserter is a medical device that received FDA 510(k) clearance on 2018-03-21. The listed applicant is Cayenne Medical, Inc.. The 510(k) number is K180274.

When did Ventix Link Knotless Anchor with Inserter receive FDA 510(k) clearance?

Ventix Link Knotless Anchor with Inserter received FDA 510(k) clearance on 2018-03-21, under 510(k) number K180274.

Who is the listed applicant for Ventix Link Knotless Anchor with Inserter?

The FDA 510(k) record lists Cayenne Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ventix Link Knotless Anchor with Inserter?

The FDA product code for Ventix Link Knotless Anchor with Inserter is MBI.

Other records listing Cayenne Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: MBI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.