Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter
The Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter (product code OMZ) is a Class 2 cardiovascular device regulated under 21 CFR 870.1250 in the Cardiovascular specialty (CV), cleared via 510(k). It is used for percutaneous transluminal or balloon valvuloplasty of the pulmonary valve in patients with isolated pulmonary stenosis, as well as patients with valvular pulmonary stenosis combined with minor congenital heart disease not requiring surgical intervention. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- OMZ
- Device Class
- FDA class 2
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
Definition
Catheter is used for Percutaneous Transluminal or balloon Valvuloplasty (PTV) of the pulmonary (pulmonic) valve. Used on patients with isolated pulmonary stenosis and also on patients with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K153069 | Edwards Balloon Catheter | Jan 07, 2016 | Substantially Equivalent | Edwards Lifesciences |
| K131002 | VIDA PTV DILATATON CATHETER | Jul 02, 2013 | Substantially Equivalent | C.R. Bard, Inc. |
| K122367 | BARD PTV DILATATION CATHETER | Nov 02, 2012 | Substantially Equivalent | C.R. Bard, Inc. |
| K102473 | MULLINS-X PTV CATHETER | Dec 09, 2010 | Substantially Equivalent | NuMED, Inc. |
| K014124 | NUMED COEFFICIENT PTV CATHETERS | Jan 16, 2002 | Substantially Equivalent | NuMED, Inc. |
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.