510(k) K063245 ยท OEI Drainage Catheter With Antibiotic
ELUTIA COATED CLOSED SURGICAL WOUND DRAIN
| Applicant | Bacterin International, Inc., Shelton CT, US |
| Decision | Substantially Equivalent, Nov 28, 2007 |
| Received | Oct 26, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063245
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.