GBZ · Catheter, Cholangiography
General, Plastic Surgery · 21 CFR 878.4200 · Class 1
Overview
| Product Code | GBZ |
|---|---|
| Device Name | Catheter, Cholangiography |
| 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 24)
Showing 20 most recent of 24 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K973621 | PRE-VIEW CHOLANGIOGRAPHY CLAMP | Nashville Surgical Instruments | Dec 17, 1997 | SESE |
| K944790 | FLEXIBLE LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER | Applied Medical Resources | Nov 29, 1994 | SESE |
| K942450 | ENDOPATH | Ethicon Endo-Surgery, Inc. | Aug 5, 1994 | SESE |
| K932228 | MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER | Boston Scientific Corp | Aug 10, 1993 | SESE |
| K926217 | TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE | Terumo Medical Corp. | Jul 13, 1993 | SESE |
| K926143 | ANGIOLAPCATH CHOLANGIOGRAPHY KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jul 7, 1993 | SESK |
| K924212 | STRYKER ENDOSCOPY CHOLANGIOGRAM KIT | Stryker Corp. | Jul 7, 1993 | SESK |
| K925742 | CLARUS CHOLANGIOGRAM CATHETER KIT | Clarus Medical Systems, Inc. | Jun 1, 1993 | SESK |
| K924981 | OPERATIVE CHOLANGIOGRAM CATHETER | Taut, Inc. | Apr 6, 1993 | SESE |
| K924480 | CHOLANGIOGRAPHY CLAMP | Applied Medical Resources | Mar 3, 1993 | SESE |
| K924128 | CHOLANGIOGRAPHY CATHETER | Applied Medical Resources | Feb 10, 1993 | SESE |
| K921091 | CHOLANGIOLAPCATH(TM) | Bd Becton Dickinson Vacutainer Systems Preanalytic | May 6, 1992 | SESE |
| K920643 | LAPAROSCOPIC SUCTION/IRRIGATION PROBE | O.R. Concepts, Inc. | May 6, 1992 | SESE |
| K914015 | CLEMENT-PILLING CHOLANGIOGRAPHY CATH GUIDE/CLAMP | Pilling Co. | Nov 21, 1991 | SESE |
| K903709 | SURGIMEDICS, SLP LAPAROSCOPIC CHOLANGIOGRAM CATH | Lifestream Int'L, Inc. | Oct 26, 1990 | SESE |
| K901520 | WURTZ CHOLEY CLIP (TM) | Cd Medical, Inc. | Jun 26, 1990 | SESE |
| K895285 | MENTOR DUCTAL CATHETERS | Mentor Corp. | Oct 17, 1989 | SESE |
| K873471 | LMI CHOLANGIOGRAM TRAY | Lazarus Medical Innovations, Inc. | Oct 23, 1987 | SESE |
| K870420 | PTC-6 AND PTC-8 PERCUTANEOUS CHOLANGIOGRAPHY | North Coast Medi-Tek | Apr 14, 1987 | SESD |
| K860534 | BILE ENDOPROSTHESIS SET | Angiomed U.S., Inc. | Mar 10, 1986 | SESE |
Top Applicants
- Applied Medical Resources — 3 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 2 clearances
- Angiomed U.S., Inc. — 1 clearance
- Atrium Medical Corp. — 1 clearance
- Boston Scientific Corp — 1 clearance
