Capiox SX25 Hollow Fiber Oxygenator with Detachable Hardshell Reservoir
FDA 510(k) K962667 · Terumo Medical Corp.
510(k) numberK962667
Submission
- Device name
- Capiox SX25 Hollow Fiber Oxygenator with Detachable Hardshell Reservoir
- Applicant
- Terumo Medical Corp.
Elkton, MD, US - Received
- July 9, 1996
- Decision date
- October 7, 1996
- 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 |
|---|---|---|
| K231044 | R2P NavicrossDQY · Traditional | 07/27/2023SE |
| K213531 | TR BAND Radial Compression DeviceDXC · Traditional | 12/20/2021SE |
| K193125 | R2P Destination Slender Guiding SheathDYB · Traditional | 01/06/2020SE |
| K181237 | Glidesheath Slender Tibial Pedal KitDYB · Traditional | 08/03/2018SE |
| K173831 | Glidesheath SlenderDYB · Traditional | 05/08/2018SE |
| K172995 | Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination…DYB · Traditional | 11/21/2017SE |
| K171491 | R2P Destination Slender Guiding SheathDYB · Traditional | 10/05/2017SE |
| K152173 | GlidesheathDYB · Traditional | 12/01/2015SE |
| K152525 | TR BAND Radial Compression DeviceDXC · Traditional | 11/10/2015SE |
| K151471 | Radifocus Glidewire Endoscopic WireOCY · Traditional | 09/17/2015SE |
Questions and answers
When was Capiox SX25 Hollow Fiber Oxygenator with Detachable Hardshell Reservoir cleared by the FDA?
Capiox SX25 Hollow Fiber Oxygenator with Detachable Hardshell Reservoir (K962667) received a 510(k) decision of Substantially Equivalent on October 7, 1996, 90 days after the submission was received.
What is the product code of K962667?
The FDA product code is DTZ – Oxygenator, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4350.