Solcotrans Ortho. Drainage/Reinfusion System
FDA 510(k) K883058 · Solco Basle, Inc.
510(k) numberK883058
Submission
- Device name
- Solcotrans Ortho. Drainage/Reinfusion System
- Applicant
- Solco Basle, Inc.
Rockland, MA, US - Received
- July 19, 1988
- Decision date
- October 28, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| 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 |
|---|---|---|
| K913247 | Solcotrans Orthopaedic Drainage/Reinfusion SystemCAC · Traditional | 02/25/1993SE |
| K913177 | Solcotrans Orthopaedic Drainage/Reinfusion SystemCAC · Traditional | 02/25/1993SE |
| K915867 | Solcovac Wound Drainage SystemGCY · Traditional | 08/14/1992SESK |
| K896858 | Solcotrans Intraoperative Autotransfusion SystemCAC · Traditional | 04/05/1990SE |
| K896857 | Solcotrans Orthopaedic Drainage/Reinfusion SystemCAC · Traditional | 04/05/1990SE |
| K896203 | Solcosept(Tm) Blood Transfusion FilterCAK · Traditional | 02/01/1990SE |
| K872590 | Solcotrans Chest Drainage Autotransfusion SystemCAC · Traditional | 09/04/1987SE |
| K872157 | Hall Vein StripperDWQ · Traditional | 07/07/1987SE |
| K843821 | Solco Basle Intraoperative AutottrnsfusCAC · Traditional | 10/01/1985SE |
Questions and answers
When was Solcotrans Ortho. Drainage/Reinfusion System cleared by the FDA?
Solcotrans Ortho. Drainage/Reinfusion System (K883058) received a 510(k) decision of Substantially Equivalent on October 28, 1988, 101 days after the submission was received.
What is the product code of K883058?
The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.