Ascendra Balloon Aortic Valvuloplasty Catheter
The Ascendra Balloon Aortic Valvuloplasty Catheter dilates a narrowed aortic valve before implantation of a bioprosthesis. Its coaxial catheter carries an inflatable distal balloon that…
The Ascendra Balloon Aortic Valvuloplasty Catheter dilates a narrowed aortic valve before implantation of a bioprosthesis. Its coaxial catheter carries an inflatable distal balloon that expands at the valve to perform balloon valvuloplasty. The catheter and balloon are made from polyamide.
A proximal Y-connector provides a guidewire lumen and a balloon-inflation port. An inflation device connects directly or through the supplied extension tubing. Injecting diluted contrast solution through the port marked BALLOON inflates the balloon, while two radiopaque marker bands identify its dilating section for positioning.
Size and Compatibility
The catheter is supplied with a 20 mm balloon and is compatible with a 0.035 inch guidewire and a 14 Fr sheath. It is supplied sterile and is intended for single use.
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan TT Medical, Inc. | Dongguan | Guangdong | Manufacturer | 4 |
Record
| Listed by | Edwards Lifesciences Technology Sarl, United States |
|---|---|
| FDA product code | OZT |
| Device type | Balloon Aortic Valvuloplasty |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1255 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K142199 |
| Record published | 2015-12-01 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9100BAVC | 20 MILIMETER DIAMETER NOMINAL BALLOON DIAMETER | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Z-MED™ | B. Braun Interventional Systems, Inc. | 60 |
| Z-MED II™ | B. Braun Interventional Systems, Inc. | 33 |
| True Dilatation | Bard Peripheral Vascular, Inc. | 18 |
| Inoue Balloon A | Toray Industries, Inc. | 12 |
| V8 | Intervalve, Inc. | 12 |
| KardiaPSI | Intervention Tech, Inc. ; dba Corvention | 11 |
| NuCLEUS-X™ | B. Braun Interventional Systems, Inc. | 9 |
| ValvuloPro® | Dongguan TT Medical, Inc. | 6 |
| Vida® | Bard Peripheral Vascular, Inc. | 5 |
| True Flow | Bard Peripheral Vascular, Inc. | 5 |
| OutFlo Aortic Valve Valvuloplasty Dilatation Balloon Catheter | Disa Medinotec (PTY) Ltd | 5 |
| Edwards Balloon Catheter | Edwards Lifesciences Technology Sarl | 1 |
Showing 12 of 15. All products under Balloon Aortic Valvuloplasty
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K142199 | 2014-10-29 |
| K140241 | 2014-07-03 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.