GCD · Connector, Catheter
General, Plastic Surgery · 21 CFR 878.4200 · Class 1
Overview
| Product Code | GCD |
|---|---|
| Device Name | Connector, 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 (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K952470 | ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II. | R-Group Intl. | Nov 28, 1995 | SESE |
| K940198 | L-CATH CONNECTOR ASSEMBLY | Luther Medical Products, Inc. | Dec 15, 1994 | SESE |
| K863446 | ANGIOMED HIGH PRESSURE CONNECTORS | Angiomed U.S., Inc. | Sep 23, 1986 | SESE |
| K851196 | INCISION DRAIN | Sil-Med Corp. | Jun 4, 1985 | SESE |
| K851921 | Y CONNECTOR | Sil-Med Corp. | May 17, 1985 | SESE |
| K760524 | CATHETER CONNECTOR, ARGYLE TUBING | Sherwood Medical Industries | Nov 2, 1976 | SESE |
| K760382 | CONNECTORS | B. Braun Instruments | Nov 2, 1976 | SESE |
| K760203 | TUBE, STERILE NON-CONDUCTIVE CONNECTING | Ipco Corp. | Jul 19, 1976 | SESE |
Top Applicants
- Sil-Med Corp. — 2 clearances
- Sherwood Medical Industries — 1 clearance
- R-Group Intl. — 1 clearance
- Luther Medical Products, Inc. — 1 clearance
- Ipco Corp. — 1 clearance
