FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH
K Number: K854113
·
Decision Jan 8, 1986
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
41
Applicant Total
59
Review Days
92
Basic Information
- Device Name
- CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH
- K Number
- K854113
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.4200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- AMERICAN BENTLEY
- Date Received
- October 8, 1985
- Decision Date
- January 8, 1986
- Product Code
- KRI
- 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 |
|---|---|---|---|
| KRI | Accessory Equipment, Cardiopulmonary Bypass | FDA class 1 | Cardiovascular |
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|---|---|---|---|
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| K863249 | OXYGENATOR MODEL NO. BENTLEY-10 PLUS | Oct 20, 1986 | Substantially Equivalent |
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