510(k) K140306 ยท FTM Mesh, Surgical
CORMATRIX PROTECT ECM ENVELOPE
| Applicant | Cormatrix Cardiovascular, Inc., Roswell GA, US |
| Decision | Substantially Equivalent, Aug 15, 2014 |
| Received | Feb 7, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140306
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 21, 2019 | AZIYO BIOLOGICS BioEnvelope, surgical mesh envelope. Labeled as the following:
1. BioEnvelope (Medium) (single pack);
2. BioEnvelope (Large) (single pack);
3. BioEnvelope (Extra Large) (single pack);
4. Terminated |
FTM | None listed |
| Aug 21, 2019 | AZIYO BIOLOGICS CanGaroo Envelopes labeled as the following:
1. CanGaroo Envelope (Large) (single pack);
2. CanGaroo Envelope (Medium) (single pack);
3. CanGaroo Envelope (Extra Large) (single pack);
4. C Terminated |
FTM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.