Panels › Cardiovascular › Product code OBI · Class 2
Catheter, Pressure Monitoring, Cardiac
Regulation 870.1200
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 OBI
| Company | 510(k)s | Recalls |
|---|---|---|
| Acist Medical Systems, Inc. | 1 | 0 |
| Merit Medical Systems, Inc. | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 13, 2019 | K190473 | ACIST RXi System and Navvus II Catheter Acist Medical Systems, Inc. | OBI |
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