Sarns Ingant Membrane Oxygenator
FDA 510(k) K895393 · 3M Company
510(k) numberK895393
Submission
- Device name
- Sarns Ingant Membrane Oxygenator
- Applicant
- 3M Company
Ann Arbor, MI, US - Received
- September 5, 1989
- Decision date
- December 4, 1989
- 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 |
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| K242538 | 3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rapid Steam…FRC · Traditional | 11/25/2024SE |
| K241959 | 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-reader…FRC · Traditional | 10/18/2024SE |
| K241710 | 3M Attest Super Rapid Readout Biological Indicator 1492V; 3M Attest Auto-reader 490…FRC · Traditional | 09/12/2024SE |
| K241542 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)FRC · Special | 06/27/2024SE |
| K240717 | 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen…FRC · Special | 06/27/2024SE |
| K233814 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M…FRC · Traditional | 03/15/2024SE |
| K222578 | 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)KKX · Traditional | 05/18/2023SE |
| K222508 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248JOJ · Traditional | 11/01/2022SE |
| K222152 | 3M Attest Hydrogen Peroxide Indicator Tape 1228JOJ · Traditional | 09/23/2022SE |
Questions and answers
When was Sarns Ingant Membrane Oxygenator cleared by the FDA?
Sarns Ingant Membrane Oxygenator (K895393) received a 510(k) decision of Substantially Equivalent on December 4, 1989, 90 days after the submission was received.
What is the product code of K895393?
The FDA product code is DTZ – Oxygenator, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4350.