Dideco Compact-A and Compact-M Autotransfusion Systems
FDA 510(k) K963759 · Sorin Biomedical, Inc.
510(k) numberK963759
Submission
- Device name
- Dideco Compact-A and Compact-M Autotransfusion Systems
- Applicant
- Sorin Biomedical, Inc.
Irvine, CA, US - Received
- September 18, 1996
- Decision date
- February 20, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
Other 510(k)s with product code CAC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241236 | XTRA Collection sets; XTRA Sequestration set XCAC · Special | Sorin Group Italia S.R.L. | 08/16/2024SE |
| K240426 | Aventus Clot Management SystemCAC · Traditional | Inquis Medical | 05/14/2024SE |
| 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 |
| K221483 | FlowSaver Blood Return SystemCAC · Traditional | Inari Medical, Inc. | 02/17/2023SE |
| K221722 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)CAC · Traditional | Haemonetics Corporation | 11/15/2022SE |
| 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 |
More from Fresenius Kabi AG
| 510(k) | Device | Decision |
|---|---|---|
| K990103 | Monolyth C 600 and 1200 Hollow Fiber Membrane Lung with Integrated Softshell Venous…DTZ · Traditional | 11/05/1999SE |
| K963758 | Code 150 Blood Component Collection Set and with Direct Draw LineCAC · Traditional | 02/20/1998SE |
| K964908 | VRF40 Venous Reservoir with Integral Cardiotomy FilterDTN · Traditional | 09/03/1997SE |
| K964907 | Venomidicard Pediatric Venous Reservoir with Integralcardiotomy Filter/Midicard…DTN · Traditional | 08/21/1997SE |
| K961869 | Dideco Newborn/Infant Arterial Filters: D735 Micro 20 and D736 Micro 40DTM · Traditional | 08/12/1996SE |
| K952270 | Dideco Adult Arterial Filters D732 Micro 20 W/20, D734 Micro 40 W/40 Micron ScreenDTM · Traditional | 08/21/1995SE |
| K945198 | Dideco Pediatric Arterial FiltersDTM · Traditional | 06/27/1995SE |
| K945065 | Dideco Flexible Reservoir -- Product Designation 5063DTN · Traditional | 05/19/1995SE |
| K941215 | Venomidicard Infant/ Pediatric Venous Cardiotomy ReservoirDTN · Traditional | 05/10/1995SE |
| K942582 | Sorin Blood Cardioplegia ConsoleDTQ · Traditional | 01/27/1995SE |
Questions and answers
When was Dideco Compact-A and Compact-M Autotransfusion Systems cleared by the FDA?
Dideco Compact-A and Compact-M Autotransfusion Systems (K963759) received a 510(k) decision of Substantially Equivalent on February 20, 1998, 520 days after the submission was received.
What is the product code of K963759?
The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.