OutFlo Aortic Valve Valvuloplasty Dilatation Balloon Catheter
The OutFlo Aortic Valve Valvuloplasty Dilatation Balloon Catheter expands a narrowed aortic valve during balloon aortic valvuloplasty. This sterile, single-use catheter has two lumens and…
The OutFlo Aortic Valve Valvuloplasty Dilatation Balloon Catheter expands a narrowed aortic valve during balloon aortic valvuloplasty. This sterile, single-use catheter has two lumens and advances over a guidewire, with a hub at the proximal end and a group of parallel balloons at the distal end.
When inflated, the balloons exert outward radial force while spaces between them provide a passage for blood flow. The five models differ in balloon diameter, from 18 to 28 mm, and each has a 40 mm balloon length.
Listed Item
The OutFlo Aortic Valve Valvuloplasty Dilatation Balloon Catheter is a sterile single-use device used during balloon aortic valvuloplasty to dilate a stenotic aortic valve as well as a pre and post dilatation device for the placement of TAVI (Transcatheter aortic valve implantation) heart valves.
Required Accessories
The catheter is used with a guiding catheter of at least 14F, a guidewire no larger than 0.035 inch and Y-connectors. These accessories are supplied separately.
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 | Disa Medinotec (PTY) Ltd, South Africa |
|---|---|
| FDA product code | OZT |
| Device type | Balloon Aortic Valvuloplasty |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1255 |
| Establishment | Manufacturer |
| 510(k) | K241562 |
| Record published | 2026-05-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 5 to 25 °C |
| Sizes | Balloon diameter 20 to 28 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OTF1-18040 | Balloon Diameter 20 mm | In distribution |
| OTF1-25040 | Balloon Diameter 25 mm | In distribution |
| OTF1-28040 | Balloon Diameter 28 mm | In distribution |
| OTF1-20040 | Balloon Diameter 20 mm | In distribution |
| OTF1-23040 | Balloon Diameter 23 mm | 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 |
| Edwards Balloon Catheter | Edwards Lifesciences Technology Sarl | 1 |
| Ascendra Balloon Aortic Valvuloplasty Catheter | Edwards Lifesciences Technology Sarl | 1 |
Showing 12 of 15. All products under Balloon Aortic Valvuloplasty
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241562 | 2025-03-11 |
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.