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Panels › General, Plastic Surgery › Product code GBZ · Class 1

Catheter, Cholangiography

Regulation 878.4200

0510(k)s in 12 months (24 all time)
3recalls in 12 months (27 all time)
13recalls that name a 510(k)
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Top companies in GBZ

DateFirm and productCodeLinked 510(k)
Sep 4, 2026Atrium Medical Corporation
Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);
Open, Classified
GBZNone listed
Sep 4, 2026Atrium Medical Corporation
Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case; Size(Model Number): 1. 24FR(8124), 2. 28FR(8128), 3. 32FR(8132), 4. 36FR(8136);
Open, Classified
GBZNone listed
Sep 4, 2026Atrium Medical Corporation
Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4. 32FR(8032), 5. 36FR(8036);
Open, Classified
GBZNone listed
Dec 2, 2023Atrium Medical Corporation
Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
Open, Classified
GBZK831931
Apr 21, 2022Atrium Medical Corporation
Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum. Product REF Number: 15028
Open, Classified
GBZNone listed
Oct 12, 2018Atrium Medical Corporation
Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128
Terminated
GBZK831931
Jan 20, 2017Atrium Medical Corporation
Atrium PVC 10 Fr Straight Thoracic Catheter Code Number: 8010
Terminated
GBZK831931
Jan 20, 2017Atrium Medical Corporation
Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008
Terminated
GBZK831931
Oct 26, 2016Atrium Medical Corporation
Atrium Medical 32 Fr Trocar catheter, Sterile Model Number: 8432 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
Terminated
GBZK831931
Oct 26, 2016Atrium Medical Corporation
Atrium Medical 28 Fr Trocar catheter, Sterile Model Number: 8428 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
Terminated
GBZK831931
Oct 26, 2016Atrium Medical Corporation
Atrium Medical 24 Fr Trocar catheter, Sterile Model Number: 8424 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
Terminated
GBZK831931
Oct 26, 2016Atrium Medical Corporation
Atrium Medical 20 Fr Trocar catheter, sterile Model Number: 8420 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
Terminated
GBZK831931
Oct 26, 2016Atrium Medical Corporation
Atrium Medical 16 Fr Trocar catheter Model Number: 8416 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
Terminated
GBZK831931
Oct 26, 2016Atrium Medical Corporation
Atrium Medical 12 Fr Trocar catheter, Sterile Model Number: 8412 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
Terminated
GBZK831931
Oct 26, 2016Atrium Medical Corporation
Atrium Medical 10 Fr Trocar catheter, Sterile Model Number: 8410 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
Terminated
GBZK831931
Oct 26, 2016Atrium Medical Corporation
Atrium Medical 8 Fr Trocar catheter, Sterile Model Number: 8408 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
Terminated
GBZK831931
Aug 5, 2015Atrium Medical Corporation
Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236
Terminated
GBZK831931
Jul 22, 2015American Catheter Corp
American Catheter / Cholangiogram Catheter 9100 Series.
Terminated
GBZNone listed
Jul 18, 2015Cook Inc.
Ring Transjugular Intrahepatic Access Set Product Usage: The Ring Transjugular Intrahepatic Access Sets are intended for transjugular liver access in diagnostic and interventional procedures. The Rin
Terminated
GBZNone listed
Jun 12, 2014Teleflex Medical
Taut Operative Cholangiogram Catheter, 4.5FR (1.5mm) x 76cm To facilitate the introduction of contrast media into the biliary ducts to obtain a cholangiogram during laparoscopic or open cholecystecto
Terminated
GBZNone listed
Aug 14, 2008Atrium Medical Corporation
HydraGlide XL Heparin Coated Silicone Thoracic Catheters, Increased number of eyelets, Increased Length by 6", Atrium Code # 14724, Size 24, # Eyelets 18, 10 per case
Terminated
GBZNone listed
Aug 14, 2008Atrium Medical Corporation
HydraGlide XL Heparin Coated Silicone Thoracic Catheters, Increased number of eyelets, Increased Length by 6", Atrium Code # 14720, Size 20, # Eyelets 15, 10 per case
Terminated
GBZNone listed
Aug 14, 2008Atrium Medical Corporation
HydraGlide Heparin Coated Silicone Thoracic Catheters - Mediastinal, Eyes on Top, Atrium Code # 14709, Size 9mm, # Eyelets 6, 10 per case
Terminated
GBZNone listed
Aug 14, 2008Atrium Medical Corporation
HydraGlide Heparin Coated Silicone Thoracic Catheters - Mediastinal, Eyes on Top & Bottom, Atrium Code # 14509, Size 9mm, # Eyelets 9, 10 per case
Terminated
GBZNone listed
Aug 14, 2008Atrium Medical Corporation
HydraGlide Heparin Coated Silicone Thoracic Catheters - Straight, Atrium Code # 14132, Size (Fr) 32, # Eyelets 6,
Terminated
GBZNone listed
Aug 14, 2008Atrium Medical Corporation
HydraGlide Heparin Coated Silicone Thoracic Catheters - Straight, Atrium Code # 14124, Size (Fr) 24, # Eyelets 6, 10 per case
Terminated
GBZNone listed
Aug 14, 2008Atrium Medical Corporation
HydraGlide Heparin Coated Silicone Thoracic Catheters - Straight, Atrium Code # 14120, Size (Fr) 20, # Eyelets 5, 10 per case
Terminated
GBZNone listed

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