KardiaPSI
KardiaPSI is an over-the-wire coaxial balloon catheter with a non-compliant balloon fixed at its distal tip. It is indicated for balloon aortic valvuloplasty. The filing describes separate…
KardiaPSI is an over-the-wire coaxial balloon catheter with a non-compliant balloon fixed at its distal tip.
It is indicated for balloon aortic valvuloplasty. The filing describes separate lumens for balloon inflation and guidewire positioning.
Catheter Structure
Two radiopaque marker bands sit at the balloon shoulders and are described as assisting fluoroscopic positioning across the aortic valve. The balloon is designed to reach a known diameter and length at a nominal inflation pressure of 4 ATM.
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 | Intervention Tech, Inc. ; dba Corvention, United States |
|---|---|
| FDA product code | OZT |
| Device type | Balloon Aortic Valvuloplasty |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1255 |
| 510(k) | K253855 |
| Record published | 2026-06-24 |
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 |
| Packaging | Box of 5 |
| Sizes | Balloon diameter 19 to 29 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CVPSI2425 | Balloon Diameter 24 mm | In distribution |
| CVPSI2625 | Balloon Diameter 26 mm | In distribution |
| CVPSI2925 | Balloon Diameter 29 mm | In distribution |
| CVPSI2725 | Balloon Diameter 27 mm | In distribution |
| CVPSI2525 | Balloon Diameter 25 mm | In distribution |
| CVPSI2225 | Balloon Diameter 22 mm | In distribution |
| CVPSI2325 | Balloon Diameter 23 mm | In distribution |
| CVPSI2825 | Balloon Diameter 28 mm | In distribution |
| CVPSI2025 | Balloon Diameter 20 mm | In distribution |
| CVPSI2125 | Balloon Diameter 21 mm | In distribution |
| CVPSI1925 | Balloon Diameter 19 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 |
| 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 |
| 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 |
|---|---|
| K253855 | 2026-05-06 |
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.