CELLO II Balloon Guide Catheter
Fuji Systems Corporation
FUJI SYSTEMS CORPORATION, Shin-Shirakawa Plant
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| FUJI SYSTEMS CORPORATION, Shin-Shirakawa Plant | 5 | N | 2026-01-01 | 1-23 Tsukinoiri, Kayane Shirakawa Fukushima JP 961-0004 | ||
| 3000308637 | 3000308637 | FUJI SYSTEMS CORPORATION, Shirakawa Plant | 1 | N | 2026-01-01 | Shirakawa Plant 200-2 Aza-Ohira, Odakura, Nishigo Nishi Shirakawa Gun Fukushima JP 961-8061 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 348704 | 1007397126 | K932647 | WIRE REINFORCED ENDOTRACHEAL TUBE | BTR | 1993-11-02 |
| 21140 | 1276191671 | K894883 | PHYCON ALL SILICONE BALLOON CATHETER | EZL | 1990-04-25 |
| 348704 | 1276191671 | K894883 | PHYCON ALL SILICONE BALLOON CATHETER | EZL | 1990-04-25 |
| 21140 | 1680192387 | K894337 | UNIVENT TUBE 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MM | CBI | 1989-09-29 |
| 348704 | 1680192387 | K894337 | UNIVENT TUBE 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MM | CBI | 1989-09-29 |
| 21140 | 1377197959 | K223275 | CELLO II Balloon Guide Catheter | QJP | 2022-12-09 |
| 348704 | 1377197959 | K223275 | CELLO II Balloon Guide Catheter | QJP | 2022-12-09 |
| 21140 | 1486155610 | K120781 | CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH | DQY | 2012-08-09 |
| 348704 | 1486155610 | K120781 | CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH | DQY | 2012-08-09 |
| 21140 | 1996038941 | K051522 | SILBRONCHO DOUBLE LUMEN TUBE | CBI | 2005-08-17 |
| 348704 | 1996038941 | K051522 | SILBRONCHO DOUBLE LUMEN TUBE | CBI | 2005-08-17 |
| 21140 | 1007397126 | ||||
| 21140 | 1993471090 | ||||
| 348704 | 1993471090 |
Product Codes Associated With Registrations#
PMN#
CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH
FUJI SYSTEMS CORP.
SILBRONCHO DOUBLE LUMEN TUBE
FUJI SYSTEMS CORP.
GUDID#
CELLO II Balloon Guide Catheter, 8F 90cm - The CELLO II Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravascular catheters into a selected blood vessel in the peripheral and neuro vasculature systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices.
2026-05-25
UNIVENT TUBE (TCB TYPE) - ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ventilation.
2024-01-31
UNIVENT TUBE (TCB TYPE) - ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ventilation.
2024-01-31
UNIVENT TUBE (TCB TYPE) - ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ventilation.
2024-01-31
UNIVENT TUBE (TCB TYPE) - ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ventilation.
2024-01-31
UNIVENT TUBE (TCB TYPE) - ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ventilation.
2024-01-31
UNIVENT TUBE (TCB TYPE) - ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ventilation.
2024-01-31
UNIVENT TUBE (TCB TYPE) - ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ventilation.
2024-01-31
UNIVENT TUBE (TCB TYPE) - ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ventilation.
2024-01-31
UNIVENT TUBE (TCB TYPE) - ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ventilation.
2024-01-31
UNIVENT TUBE (TCB TYPE) - ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ventilation.
2023-09-05
UNIVENT TUBE (TCB TYPE) - ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ventilation.
2023-09-05
UNIBLOCKER - UNIBLOCKER is intended for one-lung ventilation for endobronchial blockade of the left or right lung in thoracic surgery, lung resection, VATS, lobectomy, etc.
2023-09-05
SILBRONCHO (LEFT LUNG) - SILBRONCHO Tube is intended for use in airway management of surgical patients to perform one-lung ventilation in thoracic surgery, lung resection, VATS, lobectomy and etc.
2023-09-05
SILBRONCHO (LEFT LUNG) - SILBRONCHO Tube is intended for use in airway management of surgical patients to perform one-lung ventilation in thoracic surgery, lung resection, VATS, lobectomy and etc.
2023-09-05
SILBRONCHO (LEFT LUNG) - SILBRONCHO Tube is intended for use in airway management of surgical patients to perform one-lung ventilation in thoracic surgery, lung resection, VATS, lobectomy and etc.
2023-09-05
SILBRONCHO (LEFT LUNG) - SILBRONCHO Tube is intended for use in airway management of surgical patients to perform one-lung ventilation in thoracic surgery, lung resection, VATS, lobectomy and etc.
2023-09-05
SILBRONCHO (RIGHT LUNG) - SILBRONCHO Tube is intended for use in airway management of surgical patients to perform one-lung ventilation in thoracic surgery, lung resection, VATS, lobectomy and etc.
2023-09-05
SILBRONCHO (RIGHT LUNG) - SILBRONCHO Tube is intended for use in airway management of surgical patients to perform one-lung ventilation in thoracic surgery, lung resection, VATS, lobectomy and etc.
2023-09-05
SILBRONCHO (RIGHT LUNG) - SILBRONCHO Tube is intended for use in airway management of surgical patients to perform one-lung ventilation in thoracic surgery, lung resection, VATS, lobectomy and etc.
2023-09-05
SILBRONCHO (RIGHT LUNG) - SILBRONCHO Tube is intended for use in airway management of surgical patients to perform one-lung ventilation in thoracic surgery, lung resection, VATS, lobectomy and etc.
2023-09-05
UNIBLOCKER - UNIBLOCKER is intended for one-lung ventilation for endobronchial blockade of the left or right lung in thoracic surgery, lung resection, VATS, lobectomy, etc.
2023-09-01
CELLO™, Balloon Guide Catheter - The CELLO Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravascular catheters into a selected blood vessel in the peripheral and neuro vasculature systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures.
2022-01-18
CELLO™, Balloon Guide Catheter - The CELLO Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravascular catheters into a selected blood vessel in the peripheral and neuro vasculature systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures.
2022-01-18
CELLO™, Balloon Guide Catheter - The CELLO Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravascular catheters into a selected blood vessel in the peripheral and neuro vasculature systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures.
2022-01-18
CELLO™, Balloon Guide Catheter - The CELLO Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravascular catheters into a selected blood vessel in the peripheral and neuro vasculature systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures.
2022-01-18
CELLO™, Balloon Guide Catheter - The CELLO Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravascular catheters into a selected blood vess
2015-09-24
CELLO™, Balloon Guide Catheter - The CELLO Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravascular catheters into a selected blood vess
2015-09-24
CELLO™, Balloon Guide Catheter - The CELLO Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravascular catheters into a selected blood vess
2015-09-24
CELLO™, Balloon Guide Catheter - The CELLO Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravascular catheters into a selected blood vess
2015-09-24
FOLEY CATHETER 2-WAY - Foley Catheter is applied to a dysuria, uroschesis patient for urine drainage from bladder.
2015-09-24
UNIVENT TUBE (TCB TYPE) - ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ventilation.
2015-09-24
UNIVENT TUBE (TCB TYPE) - ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ventilation.
2015-09-24
UNIVENT TUBE (TCB TYPE) - ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ventilation.
2015-09-24
UNIVENT TUBE (TCB TYPE) - ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ventilation.
2015-09-24
UNIVENT TUBE (TCB TYPE) - ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ventilation.
2015-09-24
UNIVENT TUBE (TCB TYPE) - ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ventilation.
2015-09-24
UNIVENT TUBE (TCB TYPE) - ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ventilation.
2015-09-24
UNIVENT TUBE (TCB TYPE) - ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ventilation.
2015-09-24
UNIVENT TUBE (TCB TYPE) - ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ventilation.
2015-09-24