510(k) K092745 ยท KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR ETHYLENE OXIDE, MODELS: SELF AND HEAT SEAL POUCHES, HEAT SEAL TU
| Applicant | STERIS Corporation, Mentor OH, US |
| Decision | Substantially Equivalent, Nov 19, 2010 |
| Received | Sep 8, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092745
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 6, 2012 | Steris Corporation 100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to ethylene oxide sterilization. Tube maintains sterility of the enclosed medical devices until opened. Terminated |
LRT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.