Exu-Bag CSU-1200(DISPOS)CANISTER 602-2(NON-DISPOS
FDA 510(k) K852178 · American Omni Medical, Inc.
510(k) numberK852178
Submission
- Device name
- Exu-Bag CSU-1200(DISPOS)CANISTER 602-2(NON-DISPOS
- Applicant
- American Omni Medical, Inc.
Costa Mesa, CA, US - Received
- May 20, 1985
- Decision date
- December 27, 1985
- 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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| 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 |
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Questions and answers
When was Exu-Bag CSU-1200(DISPOS)CANISTER 602-2(NON-DISPOS cleared by the FDA?
Exu-Bag CSU-1200(DISPOS)CANISTER 602-2(NON-DISPOS (K852178) received a 510(k) decision of Substantially Equivalent on December 27, 1985, 221 days after the submission was received.
What is the product code of K852178?
The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.