Pharmaseal Medi-Vac Sterile Post-Op Autotrans. Sys
FDA 510(k) K893578 · Baxter Healthcare Corp
510(k) numberK893578
Submission
- Device name
- Pharmaseal Medi-Vac Sterile Post-Op Autotrans. Sys
- Applicant
- Baxter Healthcare Corp
Valencia, CA, US - Received
- May 9, 1989
- Decision date
- August 1, 1989
- 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
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 |
|---|---|---|
| K251745 | Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)DXQ · Traditional | 12/16/2025SE |
| K251640 | SIGMA Spectrum Infusion Pump with Master Drug LibraryFRN · Traditional | 07/28/2025SE |
| K251636 | Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)FRN · Traditional | 07/28/2025SE |
| K243529 | Solution Administration SetsFPA · Traditional | 03/14/2025SE |
| K242339 | Intravascular Extension Sets and AccessoriesFPA · Traditional | 02/28/2025SE |
| K242390 | Novum IQ Syringe Pump (40800BAXUS)FRN · Special | 09/05/2024SE |
| K241564 | Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISMQV · Traditional | 08/02/2024SE |
| K230665 | Dose IQ Safety SoftwarePHC · Traditional | 03/29/2024SE |
| K211122 | Novum IQ Large Volume PumpFRN · Traditional | 03/29/2024SE |
| K231849 | MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended…KDJ · Traditional | 03/12/2024SE |
Questions and answers
When was Pharmaseal Medi-Vac Sterile Post-Op Autotrans. Sys cleared by the FDA?
Pharmaseal Medi-Vac Sterile Post-Op Autotrans. Sys (K893578) received a 510(k) decision of Substantially Equivalent on August 1, 1989, 84 days after the submission was received.
What is the product code of K893578?
The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.