Chrysalis Intelligence · Product Codes · PZO

PZO · Unclassified

8 clearances · 3 unique sponsors

Device class
Regulation —
Total clearances
8
2020-12-31 → 2025-12-23
Last 12 months
1
Unique sponsors
3
Medical specialty
Review panel
Regulation number
Implant
Life-sustain / support
GMP exempt
Third-party review
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Sim&Cure 5 1 2025-12-23
Mentice Spain S.L. 2 0 2025-05-06
ArteryFlow Technology Co., Ltd. 1 0 2022-06-01
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
70553 CPT Medium CPT for cardiac CT with vessel visualization and 3D rendering
93000 CPT Low General cardiovascular diagnostic code if used for device planning
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-12-23 K253122 Sim&Cure Sim&Size
2025-05-06 K250160 Mentice Spain S.L. ANKYRAS
2024-12-14 K242124 Sim&Cure Sim&Size
2023-12-28 K230006 Mentice Spain S.L. Ankyras
2023-01-27 K222664 Sim&Cure Sim&Size
2022-06-01 K213838 ArteryFlow Technology Co., Ltd. AneuGuide
2022-01-27 K212373 Sim&Cure Sim&Size
2020-12-31 K202322 Sim&Cure Sim&Size