Autolog Autotransfusion System
FDA 510(k) K093535 · Medtronic, Inc.
510(k) numberK093535
Submission
- Device name
- Autolog Autotransfusion System
- Applicant
- Medtronic, Inc.
Minneapolis, MN, US - Received
- November 16, 2009
- Decision date
- March 22, 2010
- 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
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| K240584 | XTRA Autotransfusion System (with XTRA Bowl sets)CAC · Special | Sorin Group Italia S.R.L. | 04/29/2024SE |
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| K221722 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)CAC · Traditional | Haemonetics Corporation | 11/15/2022SE |
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| K210089 | CATSmart, Automated Blood Processing Autotransfusion SystemCAC · Special | Fresenius Kabi AG | 02/11/2021SE |
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Questions and answers
When was Autolog Autotransfusion System cleared by the FDA?
Autolog Autotransfusion System (K093535) received a 510(k) decision of Substantially Equivalent on March 22, 2010, 126 days after the submission was received.
What is the product code of K093535?
The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.