FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTRAVENOUS FILTER W/FLASH BULB
K Number: K771827
·
Decision Oct 13, 1977
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
97
Applicant Total
26
Review Days
24
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Basic Information
- Device Name
- INTRAVENOUS FILTER W/FLASH BULB
- K Number
- K771827
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Jelco Laboratories
- Date Received
- September 19, 1977
- Decision Date
- October 13, 1977
- Product Code
- FPB
- Advisory Committee
- General Hospital
- Review Advisory Committee
- CH
- 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 |
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Other Clearances by Jelco Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K791918 | JELCO WINGED INTRAVASCULAR CATHETER | Oct 2, 1979 | Substantially Equivalent |
| K791372 | JELCO & KVO CATHETER PLACEMENT UNIT | Sep 12, 1979 | Substantially Equivalent |
| K790967 | CATHETER METAL HUB/RADIOPAQUE | Jun 27, 1979 | Substantially Equivalent |
| K790968 | CATHETER METAL HUB/NONRADIOPAQUE | Jun 11, 1979 | Substantially Equivalent |
| K790471 | JELCO* DISC FILTER-0.2 MICRON | Apr 30, 1979 | Substantially Equivalent |
| K790186 | PROTECTIVSTABILIZER | Feb 26, 1979 | Substantially Equivalent |
| K790079 | NEEDLE, BLOOD COLLECTING | Feb 1, 1979 | Substantially Equivalent |
| K790107 | CATHETER TUBING MODIFICATION | Feb 1, 1979 | Substantially Equivalent |
| K781857 | TRAY, ARTERIAL BLOOD GAS SAMPLING | Dec 11, 1978 | Substantially Equivalent |
| K780896 | NEEDLES, DESIGN CHANGE, IV CATHETERS | Aug 23, 1978 | Substantially Equivalent |