Cytori Celution Cell Concentration Device
FDA 510(k) K060482 · Cytori Therapeutics, Inc.
510(k) numberK060482
Submission
- Device name
- Cytori Celution Cell Concentration Device
- Applicant
- Cytori Therapeutics, Inc.
San Diego, CA, US - Received
- February 23, 2006
- Decision date
- September 28, 2006
- 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 Cytori Celution Cell Concentration Device cleared by the FDA?
Cytori Celution Cell Concentration Device (K060482) received a 510(k) decision of Substantially Equivalent on September 28, 2006, 217 days after the submission was received.
What is the product code of K060482?
The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.