Apex Ph.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator
FDA 510(k) K020997 · Dideco S.P.A.
510(k) numberK020997
Submission
- Device name
- Apex Ph.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator
- Applicant
- Dideco S.P.A.
Waltham, MA, US - Received
- March 28, 2002
- Decision date
- April 4, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K041061 | D731 Micro 20 and D733 Micro 40 Pediatric Arterial FiltersDTM · Special | 05/06/2004SE |
| K033323 | D 903 Avant Adult Hollow Fiber Oxygenator and D 903 Avant 2 Ph.I.S.I.O. Adult Hollow…DTZ · Abbreviated | 01/13/2004SE |
| K033987 | D735 Micro 20 and D736 Micro 40 Newborn-Infant Arterial FiltersDTM · Special | 01/08/2004SE |
| K033714 | MVR 1200 PC: Sorin Monolyth Venous Reservoir 1200 PC with Phosphorylcholine CoatingDTN · Special | 12/11/2003SE |
| K032040 | Ideal Mimesys System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump…KFM · Special | 07/09/2003SE |
| K031223 | Synthesis Mimesys Adult Membrane OxygenatorDTZ · Special | 05/02/2003SE |
| K030154 | Ideal: System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bracket…KFM · Abbreviated | 03/31/2003SE |
| K021732 | DHF 0.2 Hemoconcentrator: Dideco Newborn-Infant Hemoncentration; DHR 0.6…KDI · Traditional | 11/04/2002SE |
| K022450 | Integrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial Filter…DTZ · Abbreviated | 10/22/2002SE |
| K020647 | Dideco ElectaCAC · Abbreviated | 09/05/2002SE |
Questions and answers
When was Apex Ph.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator cleared by the FDA?
Apex Ph.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator (K020997) received a 510(k) decision of Substantially Equivalent on April 4, 2002, 7 days after the submission was received.
What is the product code of K020997?
The FDA product code is DTZ – Oxygenator, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4350.