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FDA 510(k)

MICROVASCULAR ANASTOMOTIC DEVICE

K-Number: K040163 · 2004-04-16

ApplicantSynovis Micro Companies Alliance, Inc.
Decision Date2004-04-16
Product CodeMVR
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MICROVASCULAR ANASTOMOTIC DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Synovis Micro Companies Alliance, Inc.. It received FDA 510(k) clearance on 2004-04-16 under 510(k) number K040163. 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 MICROVASCULAR ANASTOMOTIC DEVICE?

MICROVASCULAR ANASTOMOTIC DEVICE is a medical device that received FDA 510(k) clearance on 2004-04-16. The listed applicant is Synovis Micro Companies Alliance, Inc.. The 510(k) number is K040163.

When did MICROVASCULAR ANASTOMOTIC DEVICE receive FDA 510(k) clearance?

MICROVASCULAR ANASTOMOTIC DEVICE received FDA 510(k) clearance on 2004-04-16, under 510(k) number K040163.

Who is the listed applicant for MICROVASCULAR ANASTOMOTIC DEVICE?

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

What is the FDA product code for MICROVASCULAR ANASTOMOTIC DEVICE?

The FDA product code for MICROVASCULAR ANASTOMOTIC DEVICE is MVR.

Related Clinical Trials

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Other records listing Synovis Micro Companies Alliance, 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.

K221843GEM Biover Microvascular ClampsK213974GEM FLOW COUPLER Monitor (GEM1020M-2)K093310GEM FLOW COUPLER DEVICE AND SYSTEM

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.K090679VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEMVioptix, Inc.K8619853M BRAND MICROVASCULAR ANASTOMOTIC COUPLER (27XX)3M Company

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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