FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14
K Number: K024097
·
Decision Feb 14, 2003
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
194
Applicant Total
5
Review Days
64
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Basic Information
- Device Name
- SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14
- K Number
- K024097
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5830
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Summit Medical , Ltd.
- Date Received
- December 12, 2002
- Decision Date
- February 14, 2003
- Product Code
- CAC
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CAC | Apparatus, Autotransfusion | FDA class 2 | Anesthesiology |
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Other Clearances by Summit Medical , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K173110 | GRAFTSITE | May 18, 2018 | Substantially Equivalent |
| K170388 | ANCHORMAN Tibial Ligament Fixation Device | Jul 25, 2017 | Substantially Equivalent |
| K022477 | SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET | Oct 25, 2002 | Substantially Equivalent |
| K022489 | SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT4514 | Oct 9, 2002 | Substantially Equivalent |