510(k) K102473
- Device
- MULLINS-X PTV CATHETER
- Applicant
- NUMED, INC.
- 510(k) number
- K102473
- Product code
- OMZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-12-09
- Date received
- 2010-08-30
- Regulation
- 870.1250
- Classification name
- Pulmonary (pulmonic) Valvuloplasty Catheters/percutaneous Valvuloplasty Catheter
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- NICHELLE LAFLESH
- Address
- 2880 Main St. Hopkinton NY US 12965 12965
FDA Registration Numbers#
- 3008500478
- 2528981
- 1018233
- 1646831
- 9617592
- 9618000
- 1721676
- 2011171
- 3006082230
- 1318694
- 2015691
- 2020394
- 3011088743
Source Documents#
Other 510(k) Records For Product Code OMZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K153069 | Edwards Balloon Catheter | Edwards Lifesciences | 2016-01-07 |
| K131002 | VIDA PTV DILATATON CATHETER | C.R. Bard, Inc. | 2013-07-02 |
| K122367 | BARD PTV DILATATION CATHETER | C.R. Bard, Inc. | 2012-11-02 |
| K014124 | NUMED COEFFICIENT PTV CATHETERS | NuMED, Inc. | 2002-01-16 |
Legacy Summary#
summary
FDA Review#
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