Chrysalis Intelligence · Product Codes · QQI

QQI · Interventional Cardiovascular Implant Simulation Software Device

Cardiovascular · 4 clearances · 2 unique sponsors

Device class
Class II
Regulation 870.1405
Total clearances
4
2021-09-08 → 2025-11-25
Last 12 months
1
Unique sponsors
2
Definition

What is Interventional Cardiovascular Implant Simulation Software Device

An interventional cardiovascular implant simulation software device is a prescription device that provides a computer simulation of an interventional cardiovascular implant device inside a patient’s cardiovascular anatomy. It performs computational modeling to predict the interaction of the interventional cardiovascular implant device with the patient-specific anatomical environment.
Medical specialty
Cardiovascular
Review panel
CV
Regulation number
870.1405
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
Feops NV 3 1 2025-11-25
Dasi Simulations 1 0 2023-05-30
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
99607 CPT Low Computer-assisted surgical navigation; general category for surgical simulation software
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-11-25 K250635 Feops NV FEops HEARTguide Simulation Application
2023-05-30 K223809 Dasi Simulations PrecisionTAVI (v1.1)
2022-02-25 K214066 Feops NV FEops HEARTguide
2021-09-08 DEN200030 Feops NV FEops HEARTguide