Scimed Membrane Oxygenator, Model 0600-2A
FDA 510(k) K883053 · Scimed Life Systems, Inc.
510(k) numberK883053
Submission
- Device name
- Scimed Membrane Oxygenator, Model 0600-2A
- Applicant
- Scimed Life Systems, Inc.
Minneapolis, MN, US - Received
- July 19, 1988
- Decision date
- September 26, 1988
- 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 |
|---|---|---|
| K974241 | Scimed Informer Pressure Wire SystemDQX · Traditional | 11/12/1998SE |
| K981788 | Scimed 6 French Wiseguide Guide CatheterDQO · Traditional | 08/18/1998SE |
| K980360 | Scimed Quest Floppy and Moderate Support Guide WiresDQX · Traditional | 04/29/1998SE |
| K974559 | Scimed 6 French Impulse Angiographic CathetersDQO · Traditional | 02/23/1998SE |
| K974684 | Scimed 7 French Wiseguide Guide CatheterDQY · Traditional | 02/19/1998SE |
| K973945 | Luge Guide WireDQX · Traditional | 01/12/1998SE |
| K970823 | Scimed 8 French Wiseguide Guide CatheterDQY · Traditional | 06/03/1997SE |
| K964551 | Choice Super Support Ptca Guide Wire, Choice Plus Super Support Ptca Guide Wire, Choice…DQX · Traditional | 05/21/1997SE |
| K970244 | Scimed Choice Family of Ptca Guide WiresDQX · Traditional | 03/28/1997SE |
| K965023 | Choice PT Plus Ptca Guide Wire and Choice PT Vision Ptca Guide WireDQX · Traditional | 03/04/1997SE |
Questions and answers
When was Scimed Membrane Oxygenator, Model 0600-2A cleared by the FDA?
Scimed Membrane Oxygenator, Model 0600-2A (K883053) received a 510(k) decision of Substantially Equivalent on September 26, 1988, 69 days after the submission was received.
What is the product code of K883053?
The FDA product code is DTZ – Oxygenator, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4350.