FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CAVH/CVVH/CAVHD SET MODEL #HT-HF/505
K Number: K921597
·
Decision Feb 24, 1995
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
76
Applicant Total
4
Review Days
1057
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Basic Information
- Device Name
- CAVH/CVVH/CAVHD SET MODEL #HT-HF/505
- K Number
- K921597
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Haemotronic, Inc.
- Date Received
- April 3, 1992
- Decision Date
- February 24, 1995
- Product Code
- FJK
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | FDA class 2 | Gastroenterology, Urology |
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