Sarns SM03 Membrane Oxygenator W/ Integrated Reser
FDA 510(k) K912920 · 3M Health Care, Ltd.
510(k) numberK912920
Submission
- Device name
- Sarns SM03 Membrane Oxygenator W/ Integrated Reser
- Applicant
- 3M Health Care, Ltd.
Ann Arbor, MI, US - Received
- July 3, 1991
- Decision date
- September 25, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
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| K953904 | Sarns 9000 Universal Roller PumpDWB · Traditional | 04/19/1996SE |
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| K941534 | Modular VS-22 Cemented Femoral Hip SystemKWY · Traditional | 03/06/1995SE |
| K941748 | Steri-Vac Gas Sterilizer Model 8XLFLF · Traditional | 12/02/1994SE |
| K930681 | 3M Prevention Fabric Surgical Gown #78XXFYA · Traditional | 02/10/1994SE |
| K932307 | 3M Maxi-Driver II Dbattery Powered SystemKIJ · Traditional | 01/07/1994SE |
| K932422 | 3M Tegaderm HP Transparent DressingKGX · Traditional | 12/27/1993SE |
| K932446 | Injection SiteFPA · Traditional | 11/29/1993SE |
| K931968 | Cdi 100 Extracorporeal Hematocrit/Oxygen SaturatioDRY · Traditional | 11/10/1993SE |
| K933006 | Avi Infusion Pumps, Additional Intended UseFRN · Traditional | 10/25/1993SE |
Questions and answers
When was Sarns SM03 Membrane Oxygenator W/ Integrated Reser cleared by the FDA?
Sarns SM03 Membrane Oxygenator W/ Integrated Reser (K912920) received a 510(k) decision of Substantially Equivalent on September 25, 1991, 84 days after the submission was received.
What is the product code of K912920?
The FDA product code is DTZ – Oxygenator, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4350.