Intervention Tech, Inc. ; dba Corvention · Class II · Cleared May 6, 2026
| K-number | K253855 |
| Device name | KardiaPSI Balloon Catheter |
| Applicant | Intervention Tech, Inc. ; dba Corvention |
| Product code | OZT |
| Device class | Class II |
| Decision date | May 6, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.1255 |
The KardiaPSI™ Balloon Catheter is an over-the-wire coaxial catheter with a non-compliant balloon at the distal tip, used to perform balloon aortic valvuloplasty. It is 120 cm long with two lumens: one for balloon inflation/deflation and one for guidewire positioning. It features two radiopaque marker bands for fluoroscopic positioning across the aortic valve.
The device is available in sizes completely within the dimensional range of the predicate device for both catheter and balloon. It has comparable shape, materials, manufacturing processes, catheter configuration, user interface, and nominal inflation pressures (4 ATM). The key difference is that the balloon rated burst pressure is greater than the predicate, which was tested per ISO 10555-4:2023 without raising new safety or effectiveness concerns.
ISO 10555-1:2023 and ISO 10555-4:2023 for catheter and balloon verification; ISO 11135:2014 for sterility validation; ISO 11607-1:2019 for sterile barrier packaging; ISO 10993-5, 10, 23, 11 and USP <151> for biocompatibility; ASTM F2382 and F2888 for thromboresistance and hematology testing.
The KardiaPSI™ Balloon Catheter is substantially equivalent because it has identical intended use (balloon aortic valvuloplasty) and the same principle of operation as the predicate device. No clinical, technical, or biological differences raise new safety or effectiveness questions; the higher burst pressure represents an improvement that does not introduce new hazards or limitations.
View the full FDA submission: accessdata.fda.gov