FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SERAFLO(TM) BLOODLINES FOR HEMODIALYSIS
K Number: K864784
·
Decision Jan 20, 1987
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
76
Applicant Total
11
Review Days
43
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Basic Information
- Device Name
- SERAFLO(TM) BLOODLINES FOR HEMODIALYSIS
- K Number
- K864784
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Cd Medical, Inc.
- Date Received
- December 8, 1986
- Decision Date
- January 20, 1987
- 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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Other Clearances by Cd Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K925654 | CD HOME DIALYSERVICE HEMODIALYSIS TRAY | Mar 30, 1994 | Unknown |
| K910215 | DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYST | Apr 9, 1991 | Substantially Equivalent |
| K901520 | WURTZ CHOLEY CLIP (TM) | Jun 26, 1990 | Substantially Equivalent |
| K894106 | DRAKE WILLOCK REVERSE OSMOSIS WATER TREATMENT SYST | Nov 8, 1989 | Substantially Equivalent |
| K884353 | ULTRX(TM) 850 ARTIFICIAL KIDNEY | Dec 8, 1988 | Substantially Equivalent |
| K880459 | 480 HIGH-FLOW ULTRAFILTRATION CONTROL DIALYSATE | Apr 13, 1988 | Substantially Equivalent |
| K873279 | 8810 PUMP-PUMP SINGLE NEEDLE DEVICE | Oct 23, 1987 | Substantially Equivalent |
| K862304 | DRAKE WILLOCK CENTRAL DIALYSATE DELIVERY SYSTEM | Sep 9, 1986 | Substantially Equivalent |
| K853513 | DRAKE WILLOCK 480 UF CONTROL IDALYSATE DELIVERY SY | Nov 6, 1985 | Substantially Equivalent |
| K844185 | MODIFIED C-DAK | Jan 3, 1985 | Substantially Equivalent |