FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
I.V. FILTER-PREVENT
K Number: K813454
·
Decision Jan 5, 1982
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
97
Applicant Total
6
Review Days
26
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
- I.V. FILTER-PREVENT
- K Number
- K813454
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Pioneer Viggo, Inc.
- Date Received
- December 10, 1981
- Decision Date
- January 5, 1982
- 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 Pioneer Viggo, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K823120 | EXACTA & CONNECTA STOPCOCKS W/EXTENSION | Nov 8, 1982 | Substantially Equivalent |
| K812159 | INTRAVASCULAR CATHETER | Aug 31, 1981 | Substantially Equivalent |
| K811171 | VASCULON II I.V. CATHETER | May 27, 1981 | Substantially Equivalent |
| K801537 | START IT WITH & WITHOUT I.V. CATH. UNIT | Sep 19, 1980 | Substantially Equivalent |
| K791809 | BLOOD TRANSFUSION MICROFILTER | Oct 26, 1979 | Substantially Equivalent |