JCY · Catheter, Infusion
General, Plastic Surgery · 21 CFR 878.4200 · Class 1
Overview
| Product Code | JCY |
|---|---|
| Device Name | Catheter, Infusion |
| Regulation | 21 CFR 878.4200 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
Recent Cleared Devices (14 of 14)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K863982 | VAS-CATH PERICARDIOCENTESIS CATHETER, SET & TRAY | Vas-Cath of Canada , Ltd. | Oct 24, 1986 | SESE |
| K840324 | SILICONE SUMP DRAIN 20 & 40 FRENCH | Superior Plastic Products Corp. | Apr 25, 1984 | SESE |
| K834615 | TRIPLE LUMEN INFUSIONCATHETERS- | Medical Components, Inc. | Feb 14, 1984 | SESE |
| K831453 | SILCATH CENTRAL CATHETER TRAY W/18 GA | Argon Medical Corp. | Jul 28, 1983 | SESE |
| K831451 | SILCATH CENTRAL CATHETER TRAY SIZE- | Argon Medical Corp. | Jun 8, 1983 | SESE |
| K822096 | CHEMOTHERAPY INFUSION CATHETER | American Heyer Schulte | Apr 12, 1983 | SESE |
| K813606 | SILICONE ELASTOMER INFUSION CATHETER | Quest Medical, Inc. | Jan 18, 1982 | SESE |
| K791372 | JELCO & KVO CATHETER PLACEMENT UNIT | Jelco Laboratories | Sep 12, 1979 | SESE |
| K771861 | CATHETER, CEBTRAL VENOUS, 2N1501 | Travenol Laboratories, S.A. | Nov 28, 1977 | SESE |
| K760760 | CATHETER, INTRAVASCULAR (ARGYLE IV SK) | Sherwood Medical Industries | Dec 9, 1976 | SESE |
| K760391 | CATHETER, VEIN (BRAUNULA) | B. Braun Instruments | Nov 2, 1976 | SESE |
| K760390 | CATHETER, VEIN (BRAUNULA T) | B. Braun Instruments | Nov 2, 1976 | SESE |
| K760381 | BLOOD TRANSFUSION SET (SANGOFIX) | B. Braun Instruments | Nov 2, 1976 | SESE |
| K760380 | INTRAVENOUS TRANSFER SET (INTRAFIX) | B. Braun Instruments | Nov 2, 1976 | SESE |
Top Applicants
- B. Braun Instruments — 4 clearances
- Argon Medical Corp. — 2 clearances
- Vas-Cath of Canada , Ltd. — 1 clearance
- Travenol Laboratories, S.A. — 1 clearance
- Superior Plastic Products Corp. — 1 clearance
