Device, Anastomotic, Microvascular
A Microvascular Anastomotic Device is a surgical device used to mechanically join (anastomose) small blood vessels during microsurgical reconstructive procedures such as free flap tissue transfers, providing a reliable and consistent vascular connection to restore blood flow. It is FDA Class 2, requiring 510(k) clearance, is classified as an implant, with product code MVR under 21 CFR 878.4300 in the General and Plastic Surgery specialty. The device is not life-sustaining.
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Basic Information
- Product Code
- MVR
- Device Class
- FDA class 2
- Regulation Number
- 878.4300
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K190499 | Gem FlowCoupler System | Sep 06, 2019 | Substantially Equivalent | Baxter/ Synovis Micro Companies Alliance, Inc. |
| K191252 | Gem FlowCoupler System | Jul 09, 2019 | Substantially Equivalent | Baxter/ Synovis Micro Companies Alliance, Inc. |
| K143589 | GEM Flow COUPLER Device and System | Jan 16, 2015 | Substantially Equivalent | Synovis Life Technologies, Inc. |
| K142309 | GEM Flow COUPLER Device and System | Sep 16, 2014 | Substantially Equivalent | Synovis Life Technologies, Inc. |
| K132727 | GEM FLOW COUPLER DEVICE AND SYSTEM | Oct 22, 2013 | Substantially Equivalent | Synovis Life Technologies, Inc. |
| K093310 | GEM FLOW COUPLER DEVICE AND SYSTEM | Feb 01, 2010 | Substantially Equivalent | Synovis Micro Companies Alliance, Inc. |
| K090679 | VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM | Apr 17, 2009 | Substantially Equivalent | Vioptix, Inc. |
| K040163 | MICROVASCULAR ANASTOMOTIC DEVICE | Apr 16, 2004 | Substantially Equivalent | Synovis Micro Companies Alliance, Inc. |
| K861985 | 3M BRAND MICROVASCULAR ANASTOMOTIC COUPLER (27XX) | Dec 04, 1986 | Substantially Equivalent | 3M Company |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.