Extracorporeal Maxima Hollow Fiber Oxygenator
FDA 510(k) K843955 · Extracorporeal Medical Specialities, Inc.
510(k) numberK843955
Submission
- Device name
- Extracorporeal Maxima Hollow Fiber Oxygenator
- Applicant
- Extracorporeal Medical Specialities, Inc.
King Of Prussia, PA, US - Received
- October 9, 1984
- Decision date
- November 29, 1984
- 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 |
|---|---|---|
| K840532 | Hemoperfusion System TP-400FLD · Traditional | 05/30/1984SE |
| K840262 | Hancock Pericardial PatchDXZ · Traditional | 05/30/1984SE |
| K840146 | Exp* 700 Parallel Plate DialyzerKOC · Traditional | 02/04/1984SE |
| K840057 | Exp* 500 Parallel Plate DialyzerKOC · Traditional | 02/04/1984SE |
| K832547 | Ultrafiltration ControllerKDI · Traditional | 01/03/1984SE |
| K831423 | Therapeutic Exchange SystemLQQ · Traditional | 01/03/1984SE |
| K833477 | Intersept 40 Micron FilterDTM · Traditional | 12/27/1983SE |
| K833476 | Intersept 40 Micron Filter W/TubingDTM · Traditional | 12/27/1983SE |
| K831424 | Therapeutic Exchange Blood TUBING-TP-101FJK · Traditional | 10/14/1983SE |
| K832053 | Single Patient Sys. II Model DM-450KOC · Traditional | 09/29/1983SE |
Questions and answers
When was Extracorporeal Maxima Hollow Fiber Oxygenator cleared by the FDA?
Extracorporeal Maxima Hollow Fiber Oxygenator (K843955) received a 510(k) decision of Substantially Equivalent on November 29, 1984, 51 days after the submission was received.
What is the product code of K843955?
The FDA product code is DTZ – Oxygenator, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4350.