Chrysalis Intelligence · Product Codes · DTZ

DTZ · Oxygenator, Cardiopulmonary Bypass

Cardiovascular · 24 clearances · 10 unique sponsors

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals
Device class
Class II
Regulation 870.4350
Total clearances
24
2020-02-28 → 2026-03-16
Last 12 months
4
Unique sponsors
10
Classification details
Medical specialty
Cardiovascular
Review panel
CV
Regulation number
870.4350
Implant
N
Life-sustain / support
Y
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
Eurosets S.R.L 4 2 2025-12-12
Sorin Group Italia S.R.L. 4 0 2023-11-16
Qura S.R.L 4 0 2024-09-12
Medtronic, Inc. 3 0 2024-06-12
Chalice Medical , Ltd. 3 0 2023-11-01
Abiomed, Inc. 2 0 2023-02-23
Medtronic Perfusion Systems 1 0 2024-07-10
Spectrum Medical S.R.L. 1 1 2026-03-12
Lifemotion Medical Technology Co., Ltd. 1 1 2026-03-16
Abbott 1 0 2022-12-01
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
99166 CPT — High Standard CPT for oxygenation and perfusion during cardiopulmonary bypass
C9356 HCPCS Tendon, porous matrix of cross-linked collagen and glycosaminoglycan matrix (tenoglide tendon protector sheet), per square centimeter ✓ CMS-verified description Medium Oxygenator device supply code
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-03-16 K253838 Lifemotion Medical Technology Co., Ltd. Lifemotion Disposable Membrane Oxygenator
2026-03-12 K240934 Spectrum Medical S.R.L. Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);
2025-12-12 K250821 Eurosets S.R.L Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073)
2025-11-24 K242503 Eurosets S.R.L Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)
2024-09-12 K231982 Qura S.R.L Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2
2024-07-10 K240666 Medtronic Perfusion Systems Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS)
2024-06-12 K241352 Medtronic, Inc. Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B)
2023-11-16 K231652 Sorin Group Italia S.R.L. D100 KIDS; D101 KIDS
2023-11-08 K231773 Qura S.R.L Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U
2023-11-01 K231414 Chalice Medical , Ltd. CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)
2023-04-06 K230640 Medtronic, Inc. Affinity Fusion™ Oxygenator System
2023-02-23 K223161 Abiomed, Inc. OXY-1 System
2022-12-01 K222297 Abbott CentriMag Pre-connected Pack
2022-01-28 K212341 Qura S.R.L Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U,Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U
2021-12-17 K203424 Qura S.R.L Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2
2021-12-10 K202510 Eurosets S.R.L AMG PMP Infant
2021-09-16 K203111 Medtronic Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System
2021-07-12 K211495 Sorin Group Italia S.R.L. EOS PMP
2021-04-01 K202206 Eurosets S.R.L AMG PMP Pediatric
2020-10-23 K200109 Abiomed, Inc. OXY-1 System
2020-09-18 K201642 Chalice Medical , Ltd. Paragon Adult Maxi PMP Oxygenator with Tubing Pack
2020-08-13 K201916 Sorin Group Italia S.R.L. Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenator
2020-06-12 K200683 Sorin Group Italia S.R.L. INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir, INSPIRE 7F DUAL Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir
2020-02-28 K191246 Chalice Medical , Ltd. Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence