FDA Product Code
FDA Product Code OMZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1250
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K153069 | Edwards Balloon Catheter | Edwards Lifesciences | 2016-01-07 | Traditional | PDF ↗ |
| K131002 | VIDA PTV DILATATON CATHETER | C.R. Bard, Inc. | 2013-07-02 | Traditional | PDF ↗ |
| K122367 | BARD PTV DILATATION CATHETER | C.R. Bard, Inc. | 2012-11-02 | Traditional | PDF ↗ |
| K102473 | MULLINS-X PTV CATHETER | NuMED, Inc. | 2010-12-09 | Traditional | PDF ↗ |
| K014124 | NUMED COEFFICIENT PTV CATHETERS | NuMED, Inc. | 2002-01-16 | Special | PDF ↗ |
Product code OMZ · Class II · Cardiovascular. Data: openFDA.