Dideco Compact-A Autotransfusion System
FDA 510(k) K940519 · Dideco
510(k) numberK940519
Submission
- Device name
- Dideco Compact-A Autotransfusion System
- Applicant
- Dideco
North Attleboro, MA, US - Received
- February 4, 1994
- Decision date
- January 19, 1995
- 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 |
|---|---|---|
| K004001 | Monolyth Mimesys Hollow Fiber OxygenatorDTZ · Abbreviated | 10/04/2001SE |
| K010478 | Dideco D901 Lilliput Hollow Fiber Oxygenator with or Without Soft Venous Reservoir Bag…DTZ · Abbreviated | 09/27/2001SE |
| K001388 | Data Master Perfusion Monitoring SystemDRY · Abbreviated | 07/28/2000SE |
| K936220 | Dideco Vacuum PumpCAC · Traditional | 01/27/1995SE |
Questions and answers
When was Dideco Compact-A Autotransfusion System cleared by the FDA?
Dideco Compact-A Autotransfusion System (K940519) received a 510(k) decision of Substantially Equivalent on January 19, 1995, 349 days after the submission was received.
What is the product code of K940519?
The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.