Pulmonary (pulmonic) Valvuloplasty Catheters/percutaneous Valvuloplasty Catheter
Cardiovascular · 21 CFR 870.1250
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.
Recent MDR events
21 adverse event reports on file
- VIDASep 9, 2024MalfunctionBard Peripheral Vascular, Inc.2020394-2024-01402
- VIDASep 6, 2024MalfunctionBard Peripheral Vascular, Inc.2020394-2024-01387
- VIDAJan 16, 2024MalfunctionBard Peripheral Vascular, Inc.2020394-2023-01393
- VIDASep 5, 2023MalfunctionBard Peripheral Vascular, Inc.2020394-2023-00645
- VIDAOct 20, 2021MalfunctionBard Peripheral Vascular, Inc.2020394-2021-01894
- VIDA BALLOON VALVULOPLASTY CATHETEROct 12, 2021MalfunctionBard Peripheral Vascular, Inc.2020394-2021-01860
- VIDA BALLOON VALVULOPLASTY CATHETEROct 12, 2021MalfunctionBard Peripheral Vascular, Inc.2020394-2021-01859
- VIDASep 29, 2021MalfunctionBard Peripheral Vascular, Inc.12546198
- VIDA PTV DILATATION CATHETERApr 29, 2021MalfunctionBard Peripheral Vascular, Inc.2020394-2021-00933
- VIDA PTV CATHETEROct 18, 2019MalfunctionBard Peripheral Vascular, Inc.2020394-2019-04097
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
17 firms currently registered for this product code
Edwards Lifesciences Llc
Draper, UT, US
Bard Peripheral Vascular, Inc.
TEMPE, AZ, US
C.r. Bard, Inc.
MADISON, GA, US
Biomerics Fmi
Athens, TX, US
Numed Canada, Inc.
CORNWALL Ontario, CA
Lynx Medical Pennsylvania
ERIE, PA, US
C.r. Bard, Inc.
COVINGTON, GA, US
Bard Reynosa S.a. De C.v.
REYNOSA Tamaulipas, MX
Edwards Lifesciences Llc
IRVINE, CA, US
Sterigenics U.s., Llc
Salt Lake City, UT, US
Sterigenics Us Llc
Los Angeles, CA, US
Cydonia Pharma Sl
valencia, ES
Numed, Inc.
Hopkinton, NY, US
510(k) clearances
5 clearances for this product code
- Edwards LifesciencesJan 7, 2016
K153069 · Edwards Balloon Catheter
- C.R. Bard, Inc.Jul 2, 2013
K131002 · VIDA PTV DILATATON CATHETER
- C.R. Bard, Inc.Nov 2, 2012
K122367 · BARD PTV DILATATION CATHETER
- NuMED, Inc.Dec 9, 2010
K102473 · MULLINS-X PTV CATHETER
- NuMED, Inc.Jan 16, 2002
K014124 · NUMED COEFFICIENT PTV CATHETERS