FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CATHETER TUBING MODIFICATION
K Number: K790107
·
Decision Feb 1, 1979
Classifications
1
FEI Numbers
210
Registration Numbers
211
Same Product Code
499
Applicant Total
26
Review Days
16
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Basic Information
- Device Name
- CATHETER TUBING MODIFICATION
- K Number
- K790107
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Jelco Laboratories
- Date Received
- January 16, 1979
- Decision Date
- February 1, 1979
- Product Code
- DQO
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQO), ordered by most recent decision date.
Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N
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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 |
| K781857 | TRAY, ARTERIAL BLOOD GAS SAMPLING | Dec 11, 1978 | Substantially Equivalent |
| K780896 | NEEDLES, DESIGN CHANGE, IV CATHETERS | Aug 23, 1978 | Substantially Equivalent |
| K780519 | FILTER TUBE | May 9, 1978 | Substantially Equivalent |