Product code KGZ
- Device name
- Accessories, Catheter
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4200
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K022306 | AART SILICONE TUBING | Aesthetic and Reconstructive Technologies, Inc. | 2002-10-10 |
| K974295 | BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING | Byron Medical | 1998-02-10 |
| K973183 | WOUND DRAINAGE HOLDER | R & D Medical Products, Inc. | 1998-01-23 |
| K955433 | DURALASTIC SILICONE TUBING | Allied Biomedical Corp. | 1996-01-26 |
| K942315 | NAVARRE PERCUTANEOUS ACCESS SET | Navarre Biomedical , Ltd. | 1994-07-08 |
| K896087 | PALESTRANT IRRIGATION AND DRAINAGE SET | North American Instrument Corp. | 1989-11-03 |
| K895041 | OPTICAL CATHETER(TM) INTRODUCER SETS | Medical Dynamics, Inc. | 1989-10-16 |
| K893406 | DESERET PRN ADAPTER | Deseret Medical, Inc. | 1989-06-22 |
| K873009 | CONCEPT SWITCHING STICK | Concept, Inc. | 1987-08-17 |
| K870014 | HCI GENERAL PURPOSE CATHETER STYLET | Health Care Innovations, Inc. | 1987-02-06 |
| K864115 | TUBEGRIPPER, DRAINAGE CATHETER & ACCESSORY FOR SU | Cathaid, Inc. | 1986-11-07 |
| K855078 | ANGIO MED DISPOSABLE PRESSURE CONNECTORS | Angiomed U.S., Inc. | 1986-02-19 |
| K842666 | NU-THOR THORACOSTOMY KIT | Intl. Medical Devices , Ltd. | 1984-09-20 |
| K821525 | DESERET UNIVERSAL LUER LOCK | Warner-Lambert Co. | 1982-06-23 |
| K821245 | DESERET OFFSET PRN ADAPTER | Warner-Lambert Co. | 1982-05-13 |
| K810531 | PERI-PATCH PERITONEAL CATHETER EXTENSION | Quinton, Inc. | 1981-03-24 |
| K810530 | PERI-PATCH GLUE MOLD | Quinton, Inc. | 1981-03-24 |
| K802367 | ARROW CATHETER CLAMP | Arrow Intl., Inc. | 1980-10-23 |
| K802286 | ARGLE LATEX PENROSE TUBING | Sherwood Medical Co. | 1980-10-23 |
| K791806 | CONPHAR ADAPT-CONNECTS STERILE, NONSTE. | Conphar, Inc. | 1979-09-21 |
| K791803 | CONPHAR CATHETER PLUG | Conphar, Inc. | 1979-09-21 |
| K790597 | SENSOMAT SIDEARM ADAPTER | Biochem International, Inc. | 1979-07-10 |
| K781846 | ADAPTER, CATHETER SHEATH | Arrow Intl., Inc. | 1978-12-12 |
| K781854 | PAD, B-D I.V. CATH. | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-12-04 |
| K780259 | CATHETERIZATION TRAY & KIT | Argon Medical Corp. | 1978-04-18 |
| K770154 | 3-WAY STOPCOCK WITH LUER-LOCK FITTING | American Viggo | 1977-02-28 |
| K760385 | EXTENSION SETS | B. Braun Instruments | 1976-11-02 |
| K760384 | STOPPERS | B. Braun Instruments | 1976-11-02 |
| K760383 | STOPCOCKS | B. Braun Instruments | 1976-11-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10198459435201 | MEDLINE INDUSTRIES, INC. | MEDLINE INDUSTRIES, INC. | 2025-07-21 |
| 10704411017882 | AMSure® Single Spike Infiltration Tubing | AMSINO INTERNATIONAL, INC. | 2025-06-23 |
| 10192253053609 | Devon | Cardinal Health 200, LLC | 2025-03-25 |
| 10192253042030 | Devon | Cardinal Health 200, LLC | 2025-03-07 |
| 10192253042023 | Devon | Cardinal Health 200, LLC | 2025-03-07 |
| 10193489068245 | NAMIC | MEDLINE INDUSTRIES, INC. | 2023-12-21 |
| 10193489140194 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2023-09-18 |
| 10193489140187 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2023-09-18 |
| 10193489068122 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2023-09-18 |
| 10193489068115 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2023-09-18 |
| 10193489068108 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2023-09-18 |
| 10801902196641 | ARROW | TELEFLEX INCORPORATED | 2022-11-08 |
| 10653160291527 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2022-01-01 |
| 10653160235132 | Centurion Medical Products Corp | MEDLINE INDUSTRIES, INC. | 2021-09-02 |
| 10195594230456 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2021-08-16 |
| 08033003344965 | NI-FLEX | H.S. HOSPITAL SERVICE SPA | 2021-03-01 |
| 10080196994007 | Medline | MEDLINE INDUSTRIES, INC. | 2021-02-04 |
| 10193489191868 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2020-04-20 |
| H862PS21SNC0 | Posi-Stick Introducer Set | URESIL, LLC | 2019-06-19 |
| 10801902148114 | ARROW | TELEFLEX INCORPORATED | 2019-04-11 |
| H7877001023310 | StarBurst | ANGIODYNAMICS, INC. | 2018-07-26 |
| 08714729735649 | Connecting Tube | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729735144 | Stainless Steel Guidewire | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729492153 | Nitinol Guidewire | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| H7877001023300 | StarBurst | ANGIODYNAMICS, INC. | 2016-09-22 |
| H965905000500 | NAMIC | NAVILYST MEDICAL, INC. | 2016-09-20 |
| 10801902121230 | ARROW | TELEFLEX INCORPORATED | 2016-09-16 |
| 10801902122848 | ARROW | TELEFLEX INCORPORATED | 2016-09-16 |
| H862PS2180 | Posi-Stick Introducer Set | URESIL, LLC | 2016-08-30 |
| 08714729862949 | Expel™ Large Capacity Drainage Catheter Connecting Tube | BOSTON SCIENTIFIC CORPORATION | 2016-08-25 |