FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FRESENIUS DISPOSABLE BLOOD LINES
K Number: K853851
·
Decision Nov 12, 1985
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
76
Applicant Total
21
Review Days
57
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Basic Information
- Device Name
- FRESENIUS DISPOSABLE BLOOD LINES
- K Number
- K853851
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Seratronics, Inc.
- Date Received
- September 16, 1985
- Decision Date
- November 12, 1985
- 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 Seratronics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K955299 | DPS 4 DIALYZER PREPARATION SYSTEM | Oct 21, 1996 | Substantially Equivalent |
| K931336 | DRS 4 DIALYZER REPROCESSING SYSTEM | Apr 18, 1996 | Substantially Equivalent |
| K944539 | DRS 4 ND DIALYZER REPROCESSING SYSTEM | Nov 29, 1995 | Substantially Equivalent |
| K923529 | DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES | Aug 29, 1994 | Substantially Equivalent |
| K914580 | DRS-4 DIALYZER REPROCESSING SYSTEM | Feb 24, 1992 | Substantially Equivalent |
| K874573 | FRESENIUS PURISTERIL 340 (TM) | Apr 25, 1988 | Substantially Equivalent |
| K874872 | FRESENIUS HEMOFLOW F3, F4, F5, F7 | Feb 19, 1988 | Substantially Equivalent |
| K870725 | FRESENIUS HEMOFLOW F6 AND F8 | May 1, 1987 | Substantially Equivalent |
| K870724 | FRESENIUS HEMOFLOW F60 AND F80 | Apr 1, 1987 | Substantially Equivalent |
| K864587 | FRESENIUS ULTRAFLUX AV400, AV600 | Mar 3, 1987 | Substantially Equivalent |