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

Needle, Catheter

Regulation 878.4200

0510(k)s in 12 months (8 all time)

0recalls in 12 months (9 all time)

0recalls that name a 510(k)

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Top companies in GCB

Company	510(k)s	Recalls
Pfm Medical Inc	0	3
Medical Dynamics, Inc.	2	0
Allegiance Healthcare Corp.	1	0
Argon Medical Devices, Inc	0	1
B.Braun Medical, Inc.	1	0
Becton Dickinson & Company	0	1
Cardinal Health	0	1
Carefusion 2200 Inc	0	1
Concord Laboratories, Inc.	1	0
Cook Incorporated	0	1

Date	Firm and product	Code	Linked 510(k)
Apr 12, 2024	Cook Incorporated Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such as paracentesis or thoracentesis. REFERENCE PART NUMBER (RPN): DTVN-5.0-19-10.0- YUEH ORDER NUMBER Open, Classified	GCB	None listed
Apr 26, 2020	Argon Medical Devices, Inc Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product Usage: The Skater Introducer System with radiopaque marker is intended for fine needle pu Terminated	GCB	None listed
Mar 26, 2020	Becton Dickinson & Company CareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use Only, Rx only, Catalog Number PIG1280T, UDI Number 01)10885403108402(17) 210930(10)0001304986 Terminated	GCB	None listed
Jul 17, 2015	Custom Healthcare Systems, Inc. Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only. Terminated	GCB	None listed
Dec 12, 2014	Pfm Medical Inc Veta Peritoneal Catheter Kit, Curled, Ref No. M7225 Product Usage: Veta Peritoneal Dialysis Catheters are intended for acute and chronic access to the peritoneal cavity. Terminated	GCB	None listed
Dec 12, 2014	Pfm Medical Inc Thoracentesis & Paracentesis Procedure Tray, Ref No. M7553, 850004 Product Usage: Short term percutaneous fluid drainage. Terminated	GCB	None listed
Dec 12, 2014	Pfm Medical Inc Rapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513 Product Usage: Short term percutaneous fluid drainage Terminated	GCB	None listed
Sep 11, 2013	Carefusion 2200 Inc * 1) Cat. 4341B; Qty. 10; Thoracentesis Tray; With Catheter; Sterile; CareFusion; 1500 Waukegan Road; McGaw Park, IL 60085 USA; * 2) Cat. 4341BSDF; Qty. 10; Safe-T Thoracentesis Tray; With Cathe Terminated	GCB	None listed
Jan 9, 2003	Cardinal Health Pharmaseal Thoracentesis Tray with Catheter, catalog number 4341B; a sterile, single use, Rx, latex free procedure tray containing a 7'' long Thoracentesis Catheter with a 14 gauge x 2'' needle, cathe Terminated	GCB	None listed

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