Cbc/Constavac Blood Conservation System
FDA 510(k) K881350 · Stryker Corp.
510(k) numberK881350
Submission
- Device name
- Cbc/Constavac Blood Conservation System
- Applicant
- Stryker Corp.
Kalamazoo, MI, US - Received
- March 30, 1988
- Decision date
- September 30, 1988
- 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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| 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 Cbc/Constavac Blood Conservation System cleared by the FDA?
Cbc/Constavac Blood Conservation System (K881350) received a 510(k) decision of Substantially Equivalent on September 30, 1988, 184 days after the submission was received.
What is the product code of K881350?
The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.