Plexus 3.5(TM) Pediatric Hollow Fiber Oxygenator
FDA 510(k) K901249 · Shiley, Inc.
510(k) numberK901249
Submission
- Device name
- Plexus 3.5(TM) Pediatric Hollow Fiber Oxygenator
- Applicant
- Shiley, Inc.
Irvine, CA, US - Received
- March 16, 1990
- Decision date
- June 11, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K920594 | Shiley Perfusion Tubing SetsDTM · Traditional | 03/18/1993SE |
| K910991 | Shiley Therapeutic Autotransfusion SystemCAC · Traditional | 11/27/1991SE |
| K911876 | Shiley Plexus(R) Venous Reservoir, PVR1200DTN · Traditional | 08/09/1991SE |
| K910923 | BCD AdvancedDTR · Traditional | 04/09/1991SE |
| K901548 | Biomedical Sensors-Shiley BGM 4000 Intra Blood GasCCC · Traditional | 01/14/1991SE |
| K903435 | Shiley Specialized Tracheostomy TubeJOH · Traditional | 10/02/1990SE |
| K901624 | Shiley Plexus Integral Reservoir Hollow Fiber Oxy.DTZ · Traditional | 07/03/1990SE |
| K901250 | Plexus 2(TM) Infant Hollow Fiber OxygenatorDTZ · Traditional | 06/11/1990SE |
| K900797 | Stockert Shiley Dual Pressure Control Module XRDXS · Traditional | 05/10/1990SE |
| K900548 | Shiley Phonation ValveBTO · Traditional | 04/23/1990SE |
Questions and answers
When was Plexus 3.5(TM) Pediatric Hollow Fiber Oxygenator cleared by the FDA?
Plexus 3.5(TM) Pediatric Hollow Fiber Oxygenator (K901249) received a 510(k) decision of Substantially Equivalent on June 11, 1990, 87 days after the submission was received.
What is the product code of K901249?
The FDA product code is DTZ – Oxygenator, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4350.