Hemovac Blood Reinfusion System
FDA 510(k) K041525 · Zimmer, Inc.
510(k) numberK041525
Submission
- Device name
- Hemovac Blood Reinfusion System
- Applicant
- Zimmer, Inc.
Dover, OH, US - Received
- June 8, 2004
- Decision date
- October 14, 2004
- 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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Questions and answers
When was Hemovac Blood Reinfusion System cleared by the FDA?
Hemovac Blood Reinfusion System (K041525) received a 510(k) decision of Substantially Equivalent on October 14, 2004, 128 days after the submission was received.
What is the product code of K041525?
The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.