Panels › Cardiovascular › Product code OMZ · Class 2
Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter
Regulation 870.1250
0510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in OMZ
| Company | 510(k)s | Recalls |
|---|---|---|
| C.R. Bard, Inc. | 2 | 0 |
| NuMED, Inc. | 2 | 0 |
| Edwards Lifesciences | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 7, 2016 | K153069 | Edwards Balloon Catheter Edwards Lifesciences | OMZ |
| Jul 2, 2013 | K131002 | VIDA PTV DILATATON CATHETER C.R. Bard, Inc. | OMZ |
| Nov 2, 2012 | K122367 | BARD PTV DILATATION CATHETER C.R. Bard, Inc. | OMZ |
| Dec 9, 2010 | K102473 | MULLINS-X PTV CATHETER NuMED, Inc. | OMZ |
| Jan 16, 2002 | K014124 | NUMED COEFFICIENT PTV CATHETERS NuMED, Inc. | OMZ |
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