Varidyne at Postoperative Orthopedic Autotransfu.
FDA 510(k) K900483 · Baxter Healthcare Corp
510(k) numberK900483
Submission
- Device name
- Varidyne at Postoperative Orthopedic Autotransfu.
- Applicant
- Baxter Healthcare Corp
Deerfield, IL, US - Received
- February 1, 1990
- Decision date
- August 29, 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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Questions and answers
When was Varidyne at Postoperative Orthopedic Autotransfu. cleared by the FDA?
Varidyne at Postoperative Orthopedic Autotransfu. (K900483) received a 510(k) decision of Substantially Equivalent on August 29, 1990, 209 days after the submission was received.
What is the product code of K900483?
The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.