FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIDECO-SHILEY BLOOD REINFUSION BAG
K Number: K872162
·
Decision Jul 21, 1987
Classifications
1
FEI Numbers
54
Registration Numbers
54
Same Product Code
194
Applicant Total
174
Review Days
47
Basic Information
- Device Name
- DIDECO-SHILEY BLOOD REINFUSION BAG
- K Number
- K872162
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5830
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- SHILEY, INC.
- Date Received
- June 4, 1987
- Decision Date
- July 21, 1987
- 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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|---|---|---|---|
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| K901250 | PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR | Jun 11, 1990 | Substantially Equivalent |
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