510(k) K100720 ยท FPA Set, Administration, Intravascular
K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING
| Applicant | Kawasumi Laboratories, Inc., Washington DC, US |
| Decision | Substantially Equivalent, Nov 18, 2010 |
| Received | Mar 15, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100720
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 24, 2014 | Navilyst Medical, Inc. Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plastic Port/F, Product Number H965450140, Catalog Number 45-014;
2) 8F/SL/Titanium Ports/NF, Product Number H965450170, Catalog Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.