Capiox RX Oxygenator with or Without Reservoir
FDA 510(k) K062381 · Terumo Cardiovascular Systems Corp.
510(k) numberK062381
Submission
- Device name
- Capiox RX Oxygenator with or Without Reservoir
- Applicant
- Terumo Cardiovascular Systems Corp.
Elkton, MD, US - Received
- August 15, 2006
- Decision date
- August 24, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTZ – Oxygenator, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4350
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
Other 510(k)s with product code DTZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253838 | Lifemotion Disposable Membrane OxygenatorDTZ · Traditional | Lifemotion Medical Technology Co., Ltd. | 03/16/2026SE |
| K240934 | Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood…DTZ · Traditional | Spectrum Medical S.R.L. | 03/12/2026SE |
| K250821 | Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR)…DTZ · Traditional | Eurosets S.R.L | 12/12/2025SE |
| K242503 | Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)DTZ · Traditional | Eurosets S.R.L | 11/24/2025SE |
| K231982 | Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2DTZ · Traditional | Qura S.R.L | 09/12/2024SE |
| K240666 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface…DTZ · Traditional | Medtronic Perfusion Systems | 07/10/2024SE |
| K241352 | Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT…DTZ · Special | Medtronic, Inc. | 06/12/2024SE |
| K231652 | D100 Kids; D101 KidsDTZ · Special | Sorin Group Italia S.R.L. | 11/16/2023SE |
| K231773 | Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum…DTZ · Traditional | Qura S.R.L | 11/08/2023SE |
| K231414 | CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)DTZ · Traditional | Chalice Medical , Ltd. | 11/01/2023SE |
More from Chalice Medical , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K234065 | CDI OneView Monitoring SystemDRY · Traditional | 04/25/2024SE |
| K221895 | Terumo Advanced Perfusion System 1DTQ · Traditional | 04/18/2023SE |
| K200091 | Capiox iCP Centrifugal PumpKFM · Traditional | 11/18/2021SE |
| K182110 | CDI Blood Parameter Monitoring System 550DRY · Traditional | 11/02/2018SE |
| K180950 | Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19…DTZ · Traditional | 06/22/2018SE |
| K172071 | Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19…DTZ · Traditional | 03/29/2018SE |
| K172220 | Advanced Perfusion System 1DTQ · Special | 08/17/2017SE |
| K163531 | Advanced Perfusion System 1DTQ · Traditional | 06/07/2017SE |
| K162843 | Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump…DWB · Special | 11/17/2016SE |
| K160206 | VirtuoSaph Plus Endoscopic Vessel Harvesting SystemGEI · Traditional | 04/21/2016SE |
Questions and answers
When was Capiox RX Oxygenator with or Without Reservoir cleared by the FDA?
Capiox RX Oxygenator with or Without Reservoir (K062381) received a 510(k) decision of Substantially Equivalent on August 24, 2006, 9 days after the submission was received.
What is the product code of K062381?
The FDA product code is DTZ – Oxygenator, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4350.