MVR — Device, Anastomotic, Microvascular Class II
FDA product code MVR covers "Device, Anastomotic, Microvascular", a Class II medical device regulated under 21 CFR 878.4300. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 9 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MVR
- Device Class
- Class II
- Regulation Number
- 878.4300
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K190499 | baxter/ synovis micro companies alliance | Gem FlowCoupler System | September 6, 2019 |
| K191252 | baxter/ synovis micro companies alliance | Gem FlowCoupler System | July 9, 2019 |
| K143589 | synovis life technologies | GEM Flow COUPLER Device and System | January 16, 2015 |
| K142309 | synovis life technologies | GEM Flow COUPLER Device and System | September 16, 2014 |
| K132727 | synovis life technologies | GEM FLOW COUPLER DEVICE AND SYSTEM | October 22, 2013 |
| K093310 | synovis micro companies alliance | GEM FLOW COUPLER DEVICE AND SYSTEM | February 1, 2010 |
| K090679 | vioptix | VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM | April 17, 2009 |
| K040163 | synovis micro companies alliance | MICROVASCULAR ANASTOMOTIC DEVICE | April 16, 2004 |
| K861985 | 3m | 3M BRAND MICROVASCULAR ANASTOMOTIC COUPLER (27XX) | December 4, 1986 |