Edwards Transfemoral Balloon Catheter
FDA 510(k) K140241 · Edwards Lifesciences, LLC
510(k) numberK140241
Submission
- Device name
- Edwards Transfemoral Balloon Catheter
- Applicant
- Edwards Lifesciences, LLC
Irvine, CA, US - Received
- January 30, 2014
- Decision date
- July 3, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OZT – Balloon Aortic Valvuloplasty
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1255
- Specialty
- Cardiovascular
A balloon aortic valvuloplasty catheter is indicated for balloon valvuloplasty of the aortic valve.
Other 510(k)s with product code OZT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253855 | KardiaPSI Balloon CatheterOZT · Traditional | Intervention Tech, Inc. ; dba Corvention | 05/06/2026SE |
| K260437 | Valvuloplasty Balloon Catheter (ValvuloPro)OZT · Special | Dongguan TT Medical, Inc. | 03/20/2026SE |
| K241562 | OutFlo Aortic Valve Dilatation Balloon CatheterOZT · Traditional | Disa Medinotec | 03/11/2025SE |
| K240967 | ValvuloPro Valvuloplasty Balloon CatheterOZT · Special | Dongguan TT Medical, Inc. | 07/31/2024SE |
| K231814 | ValvuloPro Valvuloplasty Balloon CatheterOZT · Traditional | Dongguan TT Medical, Inc. | 10/12/2023SE |
| K220881 | Inoue Balloon aOZT · Traditional | Toray Industries, Inc. | 12/18/2022SE |
| K172932 | True Flow Valvuloplasty Perfusion CatheterOZT · Traditional | C.R. Bard, Inc. | 12/13/2017SE |
| K152613 | True Flow Valvuloplasty Perfusion CatheterOZT · Traditional | C.R. Bard, Inc. | 01/19/2016SE |
| K152150 | V8 Balloon Aortic Valvuloplasty CatheterOZT · Traditional | Intervalve, Inc. | 12/18/2015SE |
| K150667 | True Dilatation Balloon Valvuloplasty CatheterOZT · Traditional | C.R. Bard, Inc. | 06/17/2015SE |
More from C.R. Bard, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K254232 | ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage…PZX · Traditional | 06/26/2026SE |
| K251326 | Respiration Rate algorithmBZQ · Traditional | 06/11/2026SE |
| K260105 | Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsDXC · Traditional | 06/05/2026SE |
| K254279 | Edwards eSheath+ introducer setDYB · Traditional | 04/17/2026SE |
| K253186 | HemoSphere Nano Monitor (HSNANO1)DQK · Traditional | 02/24/2026SE |
| K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)DQK · Traditional | 12/18/2025SE |
| K253034 | HemoSphere Stream ModuleDQK · Special | 10/21/2025SE |
| K251982 | Edwards MC3 Tricuspid annuloplasty ring (4900)KRH · Abbreviated | 09/23/2025SE |
| K251688 | Carpentier-Edwards Physio Annuloplasty Ring (4450)KRH · Abbreviated | 09/17/2025SE |
| K252364 | Edwards eSheath Optima introducer setDYB · Special | 08/29/2025SE |
Questions and answers
When was Edwards Transfemoral Balloon Catheter cleared by the FDA?
Edwards Transfemoral Balloon Catheter (K140241) received a 510(k) decision of Substantially Equivalent on July 3, 2014, 154 days after the submission was received.
What is the product code of K140241?
The FDA product code is OZT – Balloon Aortic Valvuloplasty, a Class II (moderate risk) device regulated under 21 CFR 870.1255.