Chrysalis Intelligence · Product Codes · OZT

OZT · Balloon Aortic Valvuloplasty

Cardiovascular · 6 clearances · 4 unique sponsors

Device class
Class II
Regulation 870.1255
Total clearances
6
2022-12-18 → 2026-05-06
Last 12 months
2
Unique sponsors
4
Definition

What is Balloon Aortic Valvuloplasty

A balloon aortic valvuloplasty catheter is indicated for balloon valvuloplasty of the aortic valve.
Medical specialty
Cardiovascular
Review panel
CV
Regulation number
870.1255
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Dongguan TT Medical, Inc. 3 1 2026-03-20
Intervention Tech, Inc. ; dba Corvention 1 1 2026-05-06
Toray Industries, Inc. 1 0 2022-12-18
Disa Medinotec 1 0 2025-03-11
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
92986 CPT High Balloon aortic valvuloplasty; standard percutaneous cardiovascular procedure code
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-05-06 K253855 Intervention Tech, Inc. ; dba Corvention KardiaPSI Balloon Catheter
2026-03-20 K260437 Dongguan TT Medical, Inc. Valvuloplasty Balloon Catheter (ValvuloPro)
2025-03-11 K241562 Disa Medinotec OutFlo Aortic Valve Dilatation Balloon Catheter
2024-07-31 K240967 Dongguan TT Medical, Inc. ValvuloPro Valvuloplasty Balloon Catheter
2023-10-12 K231814 Dongguan TT Medical, Inc. ValvuloPro Valvuloplasty Balloon Catheter
2022-12-18 K220881 Toray Industries, Inc. INOUE BALLOON A