Autologous Blood Management System (Abms)
FDA 510(k) K982650 · Dideco S.P.A.
510(k) numberK982650
Submission
- Device name
- Autologous Blood Management System (Abms)
- Applicant
- Dideco S.P.A.
North Attleboro, MA, US - Received
- July 30, 1998
- Decision date
- December 16, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAC – Apparatus, Autotransfusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5830
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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| K240584 | XTRA Autotransfusion System (with XTRA Bowl sets)CAC · Special | Sorin Group Italia S.R.L. | 04/29/2024SE |
| K231782 | FlowSaver Blood Return System (80-101)CAC · Special | Inari Medical, Inc. | 07/14/2023SE |
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| K201305 | Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction…CAC · Traditional | Atrium Medical Corporation | 09/03/2021SE |
| K210862 | Hemafuse SystemCAC · Traditional | Sisu Global Health | 07/29/2021SE |
| K210176 | FlowSaver Blood FilterCAC · Traditional | Inari Medical | 07/22/2021SE |
| K210089 | CATSmart, Automated Blood Processing Autotransfusion SystemCAC · Special | Fresenius Kabi AG | 02/11/2021SE |
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| K031223 | Synthesis Mimesys Adult Membrane OxygenatorDTZ · Special | 05/02/2003SE |
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| K021732 | DHF 0.2 Hemoconcentrator: Dideco Newborn-Infant Hemoncentration; DHR 0.6…KDI · Traditional | 11/04/2002SE |
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| K020647 | Dideco ElectaCAC · Abbreviated | 09/05/2002SE |
Questions and answers
When was Autologous Blood Management System (Abms) cleared by the FDA?
Autologous Blood Management System (Abms) (K982650) received a 510(k) decision of Substantially Equivalent on December 16, 1998, 139 days after the submission was received.
What is the product code of K982650?
The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.