510(k) K100124 ยท FMI Needle, Hypodermic, Single Lumen
FASTX STERNAL INTRAOSSEOUS DEVICE
| Applicant | Pyng Medical Corp., Richmond, Bc, CA |
| Decision | Substantially Equivalent, Aug 31, 2010 |
| Received | Jan 19, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100124
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 28, 2011 | Pyng Medical Corporation The product is the "FASTx Sternal Intraosseous Device".
The expiration date for the recalled products is end of June, 2012.
The device is used to insert an infusion tube into the manubrium (upper por Terminated |
FMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.