FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLYDE (TM) FILTRATION SYSTEM
K Number: K864113
·
Decision Feb 4, 1987
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
97
Applicant Total
10
Review Days
106
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CLYDE (TM) FILTRATION SYSTEM
- K Number
- K864113
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Arbor Technologies, Inc.
- Date Received
- October 21, 1986
- Decision Date
- February 4, 1987
- Product Code
- FPB
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FPB | Filter, Infusion Line | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FPB), ordered by most recent decision date.
Filter Needle for Single Use
FDA 510(k)
FDA Class 2
·General Hospital
Cathivex ¿GV filter units
FDA 510(k)
FDA Class 2
·General Hospital
NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER
FDA 510(k)
FDA Class 2
·General Hospital
ARTERIA BLOOD FILTER
FDA 510(k)
FDA Class 2
·General Hospital
PALL SUPOR AEF FILTER
FDA 510(k)
FDA Class 2
·General Hospital
0.2 U BACTERIAL FILTER
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Arbor Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K960928 | SYRINGEFILTER | Apr 4, 1997 | Substantially Equivalent |
| K964283 | AUTOPRIME | Jan 22, 1997 | Substantially Equivalent |
| K922777 | PRESSURE TUBING AND ACCESSORIES | Mar 22, 1994 | Substantially Equivalent |
| K902666 | ANESTHESIA CONDUCTION FILTER | Apr 23, 1991 | Substantially Equivalent |
| K895859 | CONTAIN(TM) | Feb 7, 1991 | Substantially Equivalent |
| K902167 | CONTAIN(TM) LASER PLUME FILTER | Jan 4, 1991 | Substantially Equivalent |
| K890844 | MICROSEPT 60/20 | Jun 7, 1989 | Substantially Equivalent |
| K874505 | CONTAIN(TM) | May 20, 1988 | Substantially Equivalent |
| K863162 | VACU-GUARD | Aug 29, 1986 | Substantially Equivalent |