Bard PTV Dilatation Catheter
FDA 510(k) K122367 · C.R. Bard, Inc.
510(k) numberK122367
Submission
- Device name
- Bard PTV Dilatation Catheter
- Applicant
- C.R. Bard, Inc.
Tempe, AZ, US - Received
- August 6, 2012
- Decision date
- November 2, 2012
- 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 |
| 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 Bard PTV Dilatation Catheter cleared by the FDA?
Bard PTV Dilatation Catheter (K122367) received a 510(k) decision of Substantially Equivalent on November 2, 2012, 88 days after the submission was received.
What is the product code of K122367?
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.