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

Catheter, Ventricular, General & Plastic Surgery

Regulation 878.4200

0510(k)s in 12 months (27 all time)

0recalls in 12 months (20 all time)

18recalls that name a 510(k)

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Top companies in GBS

Company	510(k)s	Recalls
Atrium Medical Corp.	1	19
Axiom Medical, Inc.	3	0
H.W. Andersen Products, Inc.	3	0
C.R. Bard, Inc.	2	0
Sheridan Catheter Corp.	2	0
Sherwood Medical Co.	2	0
Sil-Med Corp.	2	0
Uresil Corp.	2	0
Axiom, Inc.	1	0
Concentric Medical Inc	0	1

Date	Firm and product	Code	Linked 510(k)
Jan 12, 2011	Concentric Medical Inc Concentric 7F Balloon Guide Catheter (percutaneous catheter per 21 CFR 870.1250), REF 90072, manufactured by Concentric Medical, Inc., Mountain View, CA Product is indicated for use in facilitating th Terminated	GBS	K021899
Oct 7, 2010	Atrium Medical Corporation HydraGlide Silicone Chest Tube Catheter, 32 Fr Straight Product Code 14132 Terminated	GBS	None listed
Oct 7, 2010	Atrium Medical Corporation HydraGlide Silicone Chest Tube Catheter, 24 Fr Straight Product Code 14124 Terminated	GBS	None listed
Aug 14, 2008	Atrium Medical Corporation ATP HydraGlide Trocar - Includes Tapered ATP Stylet, Atrium Code # 9428, Size (Fr) 28, # Eyelets 2, 10 per case Terminated	GBS	K912645
Aug 14, 2008	Atrium Medical Corporation ATP HydraGlide Trocar - Includes Tapered ATP Stylet, Atrium Code # 9420, Size (Fr) 20, # Eyelets 2, 10 per case Terminated	GBS	K912645
Aug 14, 2008	Atrium Medical Corporation ATP HydraGlide Trocar - Includes Tapered ATP Stylet, Atrium Code # 9408, Size (Fr) 8, # Eyelets 2, 10 per case Terminated	GBS	K912645
Aug 14, 2008	Atrium Medical Corporation HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9136, Size (Fr) 36, # Eyelets 5, 10 per case Terminated	GBS	K912645
Aug 14, 2008	Atrium Medical Corporation HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9132, Size (Fr) 32, # Eyelets 5, 10 per case Terminated	GBS	K912645
Aug 14, 2008	Atrium Medical Corporation HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9128, Size (Fr) 28, # Eyelets 5, 10 per case Terminated	GBS	K912645
Aug 14, 2008	Atrium Medical Corporation HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9124, Size (Fr) 24, # Eyelets 4, 10 per case Terminated	GBS	K912645
Aug 14, 2008	Atrium Medical Corporation HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9120, Size (Fr) 20, # Eyelets 4, 10 per case Terminated	GBS	K912645
Aug 14, 2008	Atrium Medical Corporation HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9116, Size (Fr) 16, # Eyelets 4, 10 per case Terminated	GBS	K912645
Aug 14, 2008	Atrium Medical Corporation HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9040, Size (Fr) 40, # Eyelets 6, 10 per case Terminated	GBS	K912645
Aug 14, 2008	Atrium Medical Corporation HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9036, Size (Fr) 36, # Eyelets 6, 10 per case Terminated	GBS	K912645
Aug 14, 2008	Atrium Medical Corporation HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9032, Size (Fr) 32, # Eyelets 6, 10 per case Terminated	GBS	K912645
Aug 14, 2008	Atrium Medical Corporation HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9028, Size (Fr) 28, # Eyelets 6, 10 per case Terminated	GBS	K912645
Aug 14, 2008	Atrium Medical Corporation HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9024, Size (Fr) 24, # Eyelets 5, 10 per case Terminated	GBS	K912645
Aug 14, 2008	Atrium Medical Corporation HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9020, Size (Fr) 20, # Eyelets 4, 10 per case Terminated	GBS	K912645
Aug 14, 2008	Atrium Medical Corporation HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9016, Size (Fr) 16, # Eyelets 4, 10 per case Terminated	GBS	K912645
Aug 14, 2008	Atrium Medical Corporation HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9012, Size (Fr) 12, # Eyelets 4, 10 per case Terminated	GBS	K912645

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