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)
Top companies in GBZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Atrium Medical Corp. | 1 | 24 |
| Applied Medical Resources | 3 | 0 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 2 | 0 |
| American Catheter Corp | 0 | 1 |
| Angiomed U.S., Inc. | 1 | 0 |
| Boston Scientific Corp | 1 | 0 |
| Cd Medical, Inc. | 1 | 0 |
| Clarus Medical Systems, Inc. | 1 | 0 |
| Cook Inc. | 0 | 1 |
| Ethicon Endo-Surgery, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2026 | Atrium Medical Corporation Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case;
Size(Model Number): 1. 28FR(15028), 2. 36FR(15036); Open, Classified |
GBZ | None listed |
| Sep 4, 2026 | Atrium 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 |
GBZ | None listed |
| Sep 4, 2026 | Atrium 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 |
GBZ | None listed |
| Dec 2, 2023 | Atrium Medical Corporation Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036. Open, Classified |
GBZ | K831931 |
| Apr 21, 2022 | Atrium 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 |
GBZ | None listed |
| Oct 12, 2018 | Atrium Medical Corporation Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128 Terminated |
GBZ | K831931 |
| Jan 20, 2017 | Atrium Medical Corporation Atrium PVC 10 Fr Straight Thoracic Catheter
Code Number: 8010 Terminated |
GBZ | K831931 |
| Jan 20, 2017 | Atrium Medical Corporation Atrium PVC 8 Fr Straight Thoracic Catheter
Code Number: 8008 Terminated |
GBZ | K831931 |
| Oct 26, 2016 | Atrium 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 |
GBZ | K831931 |
| Oct 26, 2016 | Atrium 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 |
GBZ | K831931 |
| Oct 26, 2016 | Atrium 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 |
GBZ | K831931 |
| Oct 26, 2016 | Atrium 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 |
GBZ | K831931 |
| Oct 26, 2016 | Atrium 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 |
GBZ | K831931 |
| Oct 26, 2016 | Atrium 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 |
GBZ | K831931 |
| Oct 26, 2016 | Atrium 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 |
GBZ | K831931 |
| Oct 26, 2016 | Atrium 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 |
GBZ | K831931 |
| Aug 5, 2015 | Atrium Medical Corporation Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10)
Part Number: 15236 Terminated |
GBZ | K831931 |
| Jul 22, 2015 | American Catheter Corp American Catheter / Cholangiogram Catheter 9100 Series. Terminated |
GBZ | None listed |
| Jul 18, 2015 | Cook 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 |
GBZ | None listed |
| Jun 12, 2014 | Teleflex 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 |
GBZ | None listed |
| Aug 14, 2008 | Atrium 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 |
GBZ | None listed |
| Aug 14, 2008 | Atrium 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 |
GBZ | None listed |
| Aug 14, 2008 | Atrium Medical Corporation HydraGlide Heparin Coated Silicone Thoracic Catheters - Mediastinal, Eyes on Top,
Atrium Code # 14709,
Size 9mm,
# Eyelets 6,
10 per case Terminated |
GBZ | None listed |
| Aug 14, 2008 | Atrium Medical Corporation HydraGlide Heparin Coated Silicone Thoracic Catheters - Mediastinal, Eyes on Top & Bottom,
Atrium Code # 14509,
Size 9mm,
# Eyelets 9,
10 per case Terminated |
GBZ | None listed |
| Aug 14, 2008 | Atrium Medical Corporation HydraGlide Heparin Coated Silicone Thoracic Catheters - Straight,
Atrium Code # 14132,
Size (Fr) 32,
# Eyelets 6, Terminated |
GBZ | None listed |
| Aug 14, 2008 | Atrium Medical Corporation HydraGlide Heparin Coated Silicone Thoracic Catheters - Straight,
Atrium Code # 14124,
Size (Fr) 24,
# Eyelets 6,
10 per case Terminated |
GBZ | None listed |
| Aug 14, 2008 | Atrium Medical Corporation HydraGlide Heparin Coated Silicone Thoracic Catheters - Straight,
Atrium Code # 14120,
Size (Fr) 20,
# Eyelets 5,
10 per case Terminated |
GBZ | None listed |
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