Summit Medical Ltd Celltrans Postoperative Autotransfusion Set, Models AB400-10, AB400-12, AB400-14
FDA 510(k) K024097 · Summit Medical , Ltd.
510(k) numberK024097
Submission
- Device name
- Summit Medical Ltd Celltrans Postoperative Autotransfusion Set, Models AB400-10, AB400-12, AB400-14
- Applicant
- Summit Medical , Ltd.
Stevenage Hertfordshire, GB - Received
- December 12, 2002
- Decision date
- February 14, 2003
- 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 Summit Medical Ltd Celltrans Postoperative Autotransfusion Set, Models AB400-10, AB400-12, AB400-14 cleared by the FDA?
Summit Medical Ltd Celltrans Postoperative Autotransfusion Set, Models AB400-10, AB400-12, AB400-14 (K024097) received a 510(k) decision of Substantially Equivalent on February 14, 2003, 64 days after the submission was received.
What is the product code of K024097?
The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.