FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIDECO-SHILEY PREASSEMBLED SURGICAL WASH SET
K Number: K872161
·
Decision Aug 12, 1987
Classifications
1
FEI Numbers
149
Registration Numbers
150
Same Product Code
137
Applicant Total
174
Review Days
69
Basic Information
- Device Name
- DIDECO-SHILEY PREASSEMBLED SURGICAL WASH SET
- K Number
- K872161
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4290
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- SHILEY, INC.
- Date Received
- June 4, 1987
- Decision Date
- August 12, 1987
- Product Code
- DTL
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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