FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FILTER TUBE
K Number: K780519
·
Decision May 9, 1978
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
8
Applicant Total
26
Review Days
39
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Basic Information
- Device Name
- FILTER TUBE
- K Number
- K780519
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5130
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Jelco Laboratories
- Date Received
- March 31, 1978
- Decision Date
- May 9, 1978
- Product Code
- BSN
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BSN | Filter, Conduction, Anesthetic | FDA class 2 | Anesthesiology |
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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 |