DTR · Product Code · Chrysalis Intelligence

Device class

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Regulation —

Total clearances

2020-06-19 → 2026-03-12

Last 12 months

Unique sponsors

Classification details

Medical specialty

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Review panel

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Regulation number

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Implant

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Life-sustain / support

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GMP exempt

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Third-party review

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Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Spectrum Medical S.R.L.	2	1	2026-03-12
Quest Medical, Inc.	2	0	2020-11-20
Qura S.R.L	2	0	2022-05-06
Quara S.R.L.	1	0	2023-04-13
Medtronic	1	0	2024-02-23
Sorin Group Italia S.R.L.	1	0	2025-05-30

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.

Code	Type	Description	Confidence	Rationale
99166	CPT	—	Medium	Heat-exchanger component of cardiopulmonary bypass circuit
C9356	HCPCS	Tendon, porous matrix of cross-linked collagen and glycosaminoglycan matrix (tenoglide tendon protector sheet), per square centimeter ✓ CMS-verified description	Low	Bypass circuit equipment supply

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-03-12	K252541	Spectrum Medical S.R.L.	Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W
2025-07-08	K240908	Spectrum Medical , Ltd.	Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)
2025-05-30	K250150	Sorin Group Italia S.R.L.	VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)
2024-02-23	K240190	Medtronic	MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated
2023-04-13	K223879	Quara S.R.L.	Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)
2022-05-06	K220110	Qura S.R.L	Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger
2022-01-10	K212688	Qura S.R.L	Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger
2020-11-20	K201984	Quest Medical, Inc.	MPS 3 ND Myocardial Protection System
2020-06-19	K200438	Quest Medical, Inc.	MPS 3 Myocardial Protection System

DTR · Unclassified

Clearance volume by quarter

Top sponsors in this product code

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

Most recent 510(k) clearances