Edwards Balloon Catheter
FDA 510(k) K153069 · Edwards Lifesciences
510(k) numberK153069
Submission
- Device name
- Edwards Balloon Catheter
- Applicant
- Edwards Lifesciences
Irvine, CA, US - Received
- October 22, 2015
- Decision date
- January 7, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OMZ – Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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.
Other 510(k)s with product code OMZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K131002 | Vida PTV Dilataton CatheterOMZ · Traditional | C.R. Bard, Inc. | 07/02/2013SE |
| K122367 | Bard PTV Dilatation CatheterOMZ · Traditional | C.R. Bard, Inc. | 11/02/2012SE |
| K102473 | Mullins-X PTV CatheterOMZ · Traditional | NuMED, Inc. | 12/09/2010SE |
| K014124 | Numed Coefficient PTV CathetersOMZ · Special | NuMED, Inc. | 01/16/2002SE |
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Questions and answers
When was Edwards Balloon Catheter cleared by the FDA?
Edwards Balloon Catheter (K153069) received a 510(k) decision of Substantially Equivalent on January 7, 2016, 77 days after the submission was received.
What is the product code of K153069?
The FDA product code is OMZ – Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1250.