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FDA 510(k)

VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM

K-Number: K090679 · 2009-04-17

ApplicantVioptix, Inc.
Decision Date2009-04-17
Product CodeMVR
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Vioptix, Inc.. It received FDA 510(k) clearance on 2009-04-17 under 510(k) number K090679. The device is classified under product code MVR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM?

VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM is a medical device that received FDA 510(k) clearance on 2009-04-17. The listed applicant is Vioptix, Inc.. The 510(k) number is K090679.

When did VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM receive FDA 510(k) clearance?

VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM received FDA 510(k) clearance on 2009-04-17, under 510(k) number K090679.

Who is the listed applicant for VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM?

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

What is the FDA product code for VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM?

The FDA product code for VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM is MVR.

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Other records listing Vioptix, Inc. as applicant

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Related Devices (Code: MVR)

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.

K190499Gem FlowCoupler SystemBaxter/ Synovis Micro Companies Alliance, Inc.K191252Gem FlowCoupler SystemBaxter/ Synovis Micro Companies Alliance, Inc.K132727GEM FLOW COUPLER DEVICE AND SYSTEMSynovis Life Technologies, Inc.K093310GEM FLOW COUPLER DEVICE AND SYSTEMSynovis Micro Companies Alliance, Inc.K040163MICROVASCULAR ANASTOMOTIC DEVICESynovis Micro Companies Alliance, Inc.K8619853M BRAND MICROVASCULAR ANASTOMOTIC COUPLER (27XX)3M Company

Official Source

View on FDA Database →

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

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