KRH · Ring, Annuloplasty · Chrysalis Intelligence

Device class

Class II

Regulation 870.3800

Total clearances

2020-07-01 → 2026-06-18

Last 12 months

Unique sponsors

Classification details

Medical specialty

Cardiovascular

Review panel

Regulation number

870.3800

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
Genesee Biomedical, Inc.	4	0	2025-07-25
Corcym S.r.l.	3	2	2026-06-18
Edwards Lifesciences, LLC	2	0	2025-09-23
Medtronic, Inc.	1	0	2020-07-01
ABBOTT MEDICAL	1	1	2025-10-29

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.

Code	Type	Description	Confidence	Rationale
33405	CPT	—	High	Restoration of competency of incompetent mitral valve with annuloplasty
33418	CPT	—	High	Repair of tricuspid valve with annuloplasty

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-06-18	K261707	Corcym S.r.l.	MEMO 4D Curve Semirigid mitral annuloplasty ring
2026-04-14	K260498	Corcym S.r.l.	TriMemo SEMIRIGID ANNULOPLASTY RING
2025-10-29	K253232	ABBOTT MEDICAL	Seguin Annuloplasty Ring
2025-09-23	K251982	Edwards Lifesciences, LLC	Edwards MC3 Tricuspid annuloplasty ring (4900)
2025-09-17	K251688	Edwards Lifesciences, LLC	Carpentier-Edwards Physio Annuloplasty Ring (4450)
2025-07-25	K250859	Genesee Biomedical, Inc.	TransForm McCarthy Mitral Annuloplasty Ring (TF)
2024-04-09	K232599	Genesee Biomedical, Inc.	TransForm McCarthy Mitral Annuloplasty Ring (TF)
2023-05-26	K230679	Genesee Biomedical, Inc.	WellsForm Tricuspid Annuloplasty Band (WF)
2023-04-07	K230318	Corcym S.r.l.	Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring
2020-10-06	K202253	Genesee Biomedical, Inc.	TruForm Sievers Annuloplasty Ring
2020-07-01	K201449	Medtronic, Inc.	SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring