Mullins-X PTV Catheter
FDA 510(k) K102473 · NuMED, Inc.
510(k) numberK102473
Submission
- Device name
- Mullins-X PTV Catheter
- Applicant
- NuMED, Inc.
Hopkinton, NY, US - Received
- August 30, 2010
- Decision date
- December 9, 2010
- 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 |
|---|---|---|---|
| K153069 | Edwards Balloon CatheterOMZ · Traditional | Edwards Lifesciences | 01/07/2016SE |
| 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 |
| K014124 | Numed Coefficient PTV CathetersOMZ · Special | NuMED, Inc. | 01/16/2002SE |
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| K213915 | BIB Stent Placement CatheterNVM · Special | 01/12/2022SE |
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| K190974 | D'Vill IntroducerDYB · Special | 05/14/2019SE |
| K171206 | D'Vill IntroducerDYB · Traditional | 10/20/2017SE |
| K161451 | BIB Stent Placement CatheterNVM · Traditional | 09/22/2016SE |
| K160598 | REBOA Balloon CatheterMJN · Traditional | 06/20/2016SE |
| K160889 | BIB Stent Placement CatheterNVM · Traditional | 05/20/2016SE |
| K131869 | Pts-X Sizing Balloon CatheterMJN · Special | 08/08/2013SE |
| K122012 | Z-Med Z-Med IIOZT · Traditional | 10/04/2012SE |
Questions and answers
When was Mullins-X PTV Catheter cleared by the FDA?
Mullins-X PTV Catheter (K102473) received a 510(k) decision of Substantially Equivalent on December 9, 2010, 101 days after the submission was received.
What is the product code of K102473?
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.