Impraflo Autotransfusion Device
FDA 510(k) K901232 · Impra, Inc.
510(k) numberK901232
Submission
- Device name
- Impraflo Autotransfusion Device
- Applicant
- Impra, Inc.
Tempe, AZ, US - Received
- March 14, 1990
- Decision date
- July 18, 1990
- 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 |
|---|---|---|
| K004012 | Impra Carboflo Eptfe Vascular GraftsDYF · Traditional | 05/14/2001SE |
| K004011 | Impra Carboflo Vascular Graft, Impra Carboflo Vascular Grafts for A-V AccessDSY · Traditional | 03/27/2001SE |
| K991027 | Bi-Directional TunnelerDSY · Special | 04/22/1999SE |
| K983769 | Distaflo Bypass GraftDYF · Abbreviated | 12/15/1998SE |
| K983861 | Distaflo Bypass GraftDSY · Abbreviated | 11/24/1998SE |
| K983064 | Impra High Porosity GraftDSY · Traditional | 11/19/1998SE |
| K981079 | Venaflo PTFE Vascular Graft, Venaflo Graft with Carbon, Venaflo Vascular GraftDSY · Traditional | 05/07/1998SE |
| K981076 | Venaflo PTFE Vascular Graft, Venaflo Graft with Carbon, Venaflo Vascular GraftDYF · Traditional | 05/07/1998SE |
| K971192 | Impra Eptfe Arteriovenous Cuffed GraftDSY · Traditional | 04/15/1997ST |
| K964877 | Impra Eptfe Arteriovenous Cuffed GraftDYF · Traditional | 03/20/1997ST |
Questions and answers
When was Impraflo Autotransfusion Device cleared by the FDA?
Impraflo Autotransfusion Device (K901232) received a 510(k) decision of Substantially Equivalent on July 18, 1990, 126 days after the submission was received.
What is the product code of K901232?
The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.