MVRClass II
Device, Anastomotic, Microvascular
21 CFR 878.4300 / General, Plastic Surgery
MVR is the FDA product code for Device, Anastomotic, Microvascular, a class II device type, regulated under 21 CFR 878.4300. As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and 6 recalls.
Classification record
- Product code
- MVR
- Device name
- Device, Anastomotic, Microvascular
- Regulation
- 21 CFR 878.4300
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 9
- Ingested recalls
- 6
Clearances, product code MVR
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1986 | 1 |
| 2004 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2019 | 2 |
Applicants with the most clearances
Product code MVR| Applicant | Clearances |
|---|---|
| Synovis Life Technologies, Inc. | 3 |
| Baxter/ Synovis Micro Companies Alliance, Inc. | 2 |
| SYNOVIS MICRO COMPANIES ALLIANCE, Inc. (a subsidiary of Baxter International Inc.) | 2 |
| 3M Company | 1 |
| Vioptix, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
