Catheter, Infusion
An infusion catheter is a tubular device inserted into a vein, body cavity, or tissue to deliver fluids, medications, or nutritional solutions directly to the intended site, commonly used in general surgical and clinical care settings. It is classified as FDA Class 1, the lowest risk designation, subject only to general controls with no premarket notification required. The product code is JCY, regulated under 21 CFR 878.4200, within the General and Plastic Surgery medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- JCY
- Device Class
- FDA class 1
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 14 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K863982 | VAS-CATH PERICARDIOCENTESIS CATHETER, SET & TRAY | Oct 24, 1986 | Substantially Equivalent | Vas-Cath of Canada , Ltd. |
| K840324 | SILICONE SUMP DRAIN 20 & 40 FRENCH | Apr 25, 1984 | Substantially Equivalent | Superior Plastic Products Corp. |
| K834615 | TRIPLE LUMEN INFUSIONCATHETERS- | Feb 14, 1984 | Substantially Equivalent | Medical Components, Inc. |
| K831453 | SILCATH CENTRAL CATHETER TRAY W/18 GA | Jul 28, 1983 | Substantially Equivalent | Argon Medical Corp. |
| K831451 | SILCATH CENTRAL CATHETER TRAY SIZE- | Jun 08, 1983 | Substantially Equivalent | Argon Medical Corp. |
| K822096 | CHEMOTHERAPY INFUSION CATHETER | Apr 12, 1983 | Substantially Equivalent | American Heyer Schulte |
| K813606 | SILICONE ELASTOMER INFUSION CATHETER | Jan 18, 1982 | Substantially Equivalent | Quest Medical, Inc. |
| K791372 | JELCO & KVO CATHETER PLACEMENT UNIT | Sep 12, 1979 | Substantially Equivalent | Jelco Laboratories |
| K771861 | CATHETER, CEBTRAL VENOUS, 2N1501 | Nov 28, 1977 | Substantially Equivalent | Travenol Laboratories, S.A. |
| K760760 | CATHETER, INTRAVASCULAR (ARGYLE IV SK) | Dec 09, 1976 | Substantially Equivalent | Sherwood Medical Industries |
| K760391 | CATHETER, VEIN (BRAUNULA) | Nov 02, 1976 | Substantially Equivalent | B. Braun Instruments |
| K760390 | CATHETER, VEIN (BRAUNULA T) | Nov 02, 1976 | Substantially Equivalent | B. Braun Instruments |
| K760381 | BLOOD TRANSFUSION SET (SANGOFIX) | Nov 02, 1976 | Substantially Equivalent | B. Braun Instruments |
| K760380 | INTRAVENOUS TRANSFER SET (INTRAFIX) | Nov 02, 1976 | Substantially Equivalent | B. Braun Instruments |
FEI Numbers
This FDA classification entry is associated with 37 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 37 registration numbers. Click on an entry to view related FDA registrations.