GBW · Catheter, Peritoneal
General, Plastic Surgery · 21 CFR 878.4200 · Class 1
Overview
| Product Code | GBW |
|---|---|
| Device Name | Catheter, Peritoneal |
| 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 (17 of 17)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K992907 | INTRADUCER | Taut, Inc. | Oct 5, 1999 | SESE |
| K992904 | MINI-PORT | Taut, Inc. | Oct 5, 1999 | SESE |
| K972112 | INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450 | Taut, Inc. | Dec 1, 1997 | SESE |
| K961194 | ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN | Sil-Med Corp. | Aug 8, 1996 | SESE |
| K960426 | MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETER | Medical Components, Inc. | Mar 21, 1996 | SESE |
| K942709 | MEDIASTINAL SILICONE DRAINS | Sil-Med Corp. | Jan 4, 1996 | SN |
| K933510 | ARGYLE TURKEL SAFETY TROCAR THORACIC CATHETER | Sherwood Medical Co. | Feb 24, 1994 | SESE |
| K926477 | BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO | Core Dynamics, Inc. | Nov 12, 1993 | SESE |
| K913733 | STERILE CHEST TUBE | Vascular Products, Inc. | Oct 8, 1991 | SESE |
| K894220 | HOUTS HYSTERECTOMY DRAIN | Helix Medical, Inc. | Aug 24, 1989 | SESE |
| K894119 | MADEGOM LTDA. PENROSE DRAIN TUBING | Madegom | Aug 18, 1989 | SESE |
| K854812 | NELSON-JUNG PLEURAL CATH | Research Medical, Inc. | Feb 11, 1986 | SESE |
| K843575 | DERBYSHIRE DRAIN | Sil-Med Corp. | Oct 24, 1984 | SESE |
| K813063 | FLAT DRAIN | Sil-Med Corp. | Dec 18, 1981 | SESE |
| K811627 | ARROW PERITONEAL LAVAGE CATHERIZATION K | Arrow Intl., Inc. | Aug 10, 1981 | SESE |
| K811378 | PERCUTANEOUS DRAINING CATHETER | Medi-Tech, Inc. | Jun 2, 1981 | SESE |
| K800422 | ADT MINI PERITONEAL LAVAGE KIT | A.D.T. Lab Industries | Mar 12, 1980 | SESE |
Top Applicants
- Sil-Med Corp. — 4 clearances
- Taut, Inc. — 3 clearances
- A.D.T. Lab Industries — 1 clearance
- Arrow Intl., Inc. — 1 clearance
- Core Dynamics, Inc. — 1 clearance
