510(k) K053188 ยท NKU Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed
REPROCESSED BALOON INFLATION DEVICE
| Applicant | Sterilmed, Inc., Maple Grove MN, US |
| Decision | Substantially Equivalent, May 4, 2006 |
| Received | Nov 15, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053188
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 13, 2009 | Sterilmed Inc Balloon Inflation Device
Model #'s:
MED15-105
MED15-106 and
SCI04527-01
The reprocessed Balloon inflation device is intended for use with balloon dilatation catheters to create and monitor pressur Terminated |
NKU | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.