Panels › Cardiovascular › Product code NKU · Class 2
Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed
Regulation 870.1650
0510(k)s in 12 months (1 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in NKU
| Company | 510(k)s | Recalls |
|---|---|---|
| Sterilmed, Inc. | 1 | 1 |
| 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 | K053188 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.