KGZ · Accessories, Catheter
General, Plastic Surgery · 21 CFR 878.4200 · Class 1
Overview
| Product Code | KGZ |
|---|---|
| Device Name | Accessories, Catheter |
| 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 (20 of 29)
Showing 20 most recent of 29 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K022306 | AART SILICONE TUBING | Aesthetic and Reconstructive Technologies, Inc. | Oct 10, 2002 | SESE |
| K974295 | BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING | Byron Medical | Feb 10, 1998 | SESE |
| K973183 | WOUND DRAINAGE HOLDER | R & D Medical Products, Inc. | Jan 23, 1998 | SESE |
| K955433 | DURALASTIC SILICONE TUBING | Allied Biomedical Corp. | Jan 26, 1996 | SESE |
| K942315 | NAVARRE PERCUTANEOUS ACCESS SET | Navarre Biomedical , Ltd. | Jul 8, 1994 | SESE |
| K896087 | PALESTRANT IRRIGATION AND DRAINAGE SET | North American Instrument Corp. | Nov 3, 1989 | SESE |
| K895041 | OPTICAL CATHETER(TM) INTRODUCER SETS | Medical Dynamics, Inc. | Oct 16, 1989 | SESE |
| K893406 | DESERET PRN ADAPTER | Deseret Medical, Inc. | Jun 22, 1989 | SESE |
| K873009 | CONCEPT SWITCHING STICK | Concept, Inc. | Aug 17, 1987 | SESE |
| K870014 | HCI GENERAL PURPOSE CATHETER STYLET | Health Care Innovations, Inc. | Feb 6, 1987 | SESE |
| K864115 | TUBEGRIPPER, DRAINAGE CATHETER & ACCESSORY FOR SU | Cathaid, Inc. | Nov 7, 1986 | SESE |
| K855078 | ANGIO MED DISPOSABLE PRESSURE CONNECTORS | Angiomed U.S., Inc. | Feb 19, 1986 | SESE |
| K842666 | NU-THOR THORACOSTOMY KIT | Intl. Medical Devices , Ltd. | Sep 20, 1984 | SESE |
| K821525 | DESERET UNIVERSAL LUER LOCK | Warner-Lambert Co. | Jun 23, 1982 | SESE |
| K821245 | DESERET OFFSET PRN ADAPTER | Warner-Lambert Co. | May 13, 1982 | SESE |
| K810531 | PERI-PATCH PERITONEAL CATHETER EXTENSION | Quinton, Inc. | Mar 24, 1981 | SESE |
| K810530 | PERI-PATCH GLUE MOLD | Quinton, Inc. | Mar 24, 1981 | SESE |
| K802367 | ARROW CATHETER CLAMP | Arrow Intl., Inc. | Oct 23, 1980 | SESE |
| K802286 | ARGLE LATEX PENROSE TUBING | Sherwood Medical Co. | Oct 23, 1980 | SESE |
| K791806 | CONPHAR ADAPT-CONNECTS STERILE, NONSTE. | Conphar, Inc. | Sep 21, 1979 | SESE |
Top Applicants
- B. Braun Instruments — 3 clearances
- Arrow Intl., Inc. — 2 clearances
- Conphar, Inc. — 2 clearances
- Quinton, Inc. — 2 clearances
- Warner-Lambert Co. — 2 clearances
