FDA product code MVR: Device, Anastomotic, Microvascular
MVR is the FDA product code for device, anastomotic, microvascular. It is a Class II device, regulated under 21 CFR 878.4300 and reviewed by the General and Plastic Surgery panel. FDA has cleared 9 510(k) submissions under MVR, from 5 different applicants. The average 510(k) review took 85 days (median 61). FDA has posted 6 recalls for MVR devices.
Classification
| Field | Value |
|---|---|
| Device name | Device, Anastomotic, Microvascular |
| Device class | Class II |
| Regulation | 21 CFR 878.4300 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for MVR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 2 | 125 |
Compare with all 510(k) review times · Search every MVR clearance
Top MVR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Synovis Life Technologies, Inc. | 3 | 2015-01-16 |
| Baxter/ Synovis Micro Companies Alliance, Inc. | 2 | 2019-09-06 |
| Synovis Micro Companies Alliance, Inc. | 2 | 2010-02-01 |
| Vioptix, Inc. | 1 | 2009-04-17 |
| 3M Company | 1 | 1986-12-04 |
Most recent MVR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K190499 | Baxter/ Synovis Micro Companies Alliance, Inc. | Gem FlowCoupler System | 2019-09-06 | 189 |
| K191252 | Baxter/ Synovis Micro Companies Alliance, Inc. | Gem FlowCoupler System | 2019-07-09 | 61 |
| K143589 | Synovis Life Technologies, Inc. | GEM Flow COUPLER Device and System | 2015-01-16 | 29 |
| K142309 | Synovis Life Technologies, Inc. | GEM Flow COUPLER Device and System | 2014-09-16 | 28 |
| K132727 | Synovis Life Technologies, Inc. | GEM FLOW COUPLER DEVICE AND SYSTEM | 2013-10-22 | 49 |
Recalls for MVR devices
6 product recalls in 4 recall events; 0 initiated in the last five years and 2 still open. Most recent: 2020-12-28.
| Year | Recalls |
|---|---|
| 2020 | 5 |
Frequently asked questions
What is FDA product code MVR?
MVR is the FDA product code for device, anastomotic, microvascular. It is a Class II device, regulated under 21 CFR 878.4300 and reviewed by the General and Plastic Surgery panel.
What device class is MVR?
Class II, regulation 21 CFR 878.4300. Typical premarket route: 510(k).
How long does a 510(k) take for product code MVR?
Across 9 cleared submissions the average was 85 days from receipt to decision (median 61).
Which companies have the most MVR clearances?
Synovis Life Technologies, Inc. (3); Baxter/ Synovis Micro Companies Alliance, Inc. (2); Synovis Micro Companies Alliance, Inc. (2); Vioptix, Inc. (1); 3M Company (1).
Have MVR devices been recalled?
Yes: 6 product recalls across 4 recall events; the most recent began 2020-12-28.
Next steps
- Run an FDA pathway report with predicate devices for product code MVR
- Run a recall and safety report across every MVR manufacturer
- Watch product code MVR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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