Panels › General, Plastic Surgery › Product code OEI · Class 2
Drainage Catheter With Antibiotic
Regulation 878.4780
0510(k)s in 12 months (1 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in OEI
| Company | 510(k)s | Recalls |
|---|---|---|
| Bacterin International, Inc. | 1 | 2 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 2, 2014 | Bacterin International, Inc. Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wound Drain***"
Two different sizes, 10 units per box:
19 Fr Round Hubless part number 7110;
24 Fr Round Hubless part num Terminated |
OEI | K063245 |
| Mar 11, 2013 | Bacterin International, Inc. Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver Sulfadiazine STERILE, Box of 10 Part #7118. Indicated for use in surgical wound draina Terminated |
OEI | K063245 |
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