Autotransfusion Suction Reservoir with Filter
FDA 510(k) K940678 · Baxter Healthcare Corp
510(k) numberK940678
Submission
- Device name
- Autotransfusion Suction Reservoir with Filter
- Applicant
- Baxter Healthcare Corp
Irvine, CA, US - Received
- February 9, 1994
- Decision date
- April 15, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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Questions and answers
When was Autotransfusion Suction Reservoir with Filter cleared by the FDA?
Autotransfusion Suction Reservoir with Filter (K940678) received a 510(k) decision of Substantially Equivalent on April 15, 1994, 65 days after the submission was received.
What is the product code of K940678?
The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.