FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CHURCHILL 1.2 MICRON LIQUID FILTER SET
K Number: K880027
·
Decision Apr 13, 1988
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
97
Applicant Total
35
Review Days
99
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
- CHURCHILL 1.2 MICRON LIQUID FILTER SET
- K Number
- K880027
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Churchill Corp.
- Date Received
- January 5, 1988
- Decision Date
- April 13, 1988
- 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 Churchill Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K880025 | CHURCHILL 0.22 MICRON LIQUID FILTER SETS | Apr 14, 1988 | Substantially Equivalent |
| K880026 | CHURCHILL 0.22 MICRON LIQUID COMPACT FILTER SETS | Apr 14, 1988 | Substantially Equivalent |
| K880051 | ENTERAL BAG/SET | Apr 14, 1988 | Substantially Equivalent |
| K872585 | CHURCHILL-CATH | Oct 15, 1987 | Substantially Equivalent |
| K870395 | CHURCHILL PARENTERAL NUTRITION BAG - EVA | Oct 15, 1987 | Substantially Equivalent |
| K872124 | CHURCHILL ALBUMIN IV ADMINISTRATION SET | Oct 13, 1987 | Substantially Equivalent |
| K872123 | CHURCHILL TPN ADMINISTRATION SET | Oct 9, 1987 | Substantially Equivalent |
| K872043 | CHURCHILL INTER-CARDIAC SUCKER | Sep 30, 1987 | Substantially Equivalent |
| K871084 | NITROGLYCERINE PUMP SET | Jul 16, 1987 | Substantially Equivalent |
| K871085 | EXTENSION TUBE PUMP SET | Jun 15, 1987 | Substantially Equivalent |