Stryker Constavac Blood Conservation System II (Cbcii)
FDA 510(k) K952224 · Stryker Instruments
510(k) numberK952224
Submission
- Device name
- Stryker Constavac Blood Conservation System II (Cbcii)
- Applicant
- Stryker Instruments
Kalamazoo, MI, US - Received
- May 12, 1995
- Decision date
- November 17, 1995
- 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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| K210862 | Hemafuse SystemCAC · Traditional | Sisu Global Health | 07/29/2021SE |
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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 Stryker Constavac Blood Conservation System II (Cbcii) cleared by the FDA?
Stryker Constavac Blood Conservation System II (Cbcii) (K952224) received a 510(k) decision of Substantially Equivalent on November 17, 1995, 189 days after the submission was received.
What is the product code of K952224?
The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.