Code 150 Blood Component Collection Set and with Direct Draw Line
FDA 510(k) K963758 · Sorin Biomedical, Inc.
510(k) numberK963758
Submission
- Device name
- Code 150 Blood Component Collection Set and with Direct Draw Line
- 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 |
| K963759 | Dideco Compact-A and Compact-M Autotransfusion SystemsCAC · 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 Code 150 Blood Component Collection Set and with Direct Draw Line cleared by the FDA?
Code 150 Blood Component Collection Set and with Direct Draw Line (K963758) 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 K963758?
The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.