Baylor Rapid Autotransfusion System
FDA 510(k) K852736 · Cardio Systems, Inc.
510(k) numberK852736
Submission
- Device name
- Baylor Rapid Autotransfusion System
- Applicant
- Cardio Systems, Inc.
The Woodlands, TX, US - Received
- May 8, 1985
- Decision date
- September 18, 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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| K210089 | CATSmart, Automated Blood Processing Autotransfusion SystemCAC · Special | Fresenius Kabi AG | 02/11/2021SE |
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Questions and answers
When was Baylor Rapid Autotransfusion System cleared by the FDA?
Baylor Rapid Autotransfusion System (K852736) received a 510(k) decision of Substantially Equivalent on September 18, 1985, 133 days after the submission was received.
What is the product code of K852736?
The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.