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510(k) K831931 · GBZ Catheter, Cholangiography

ATRIUM THORACIC CATHETER

Applicant	Atrium Medical Corp., Walker MI, US
Decision	Substantially Equivalent, Oct 4, 1983
Received	Jun 15, 1983
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K831931

Date	Firm and product	Code	Linked 510(k)
Dec 2, 2023	Atrium Medical Corporation Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036. Open, Classified	GBZ	None listed
Oct 12, 2018	Atrium Medical Corporation Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128 Terminated	GBZ	None listed
Jan 20, 2017	Atrium Medical Corporation Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008 Terminated	GBZ	None listed
Jan 20, 2017	Atrium Medical Corporation Atrium PVC 10 Fr Straight Thoracic Catheter Code Number: 8010 Terminated	GBZ	None listed
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	None listed
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	None listed
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	None listed
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	None listed
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	None listed
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	None listed
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	None listed
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	None listed
Aug 5, 2015	Atrium Medical Corporation Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236 Terminated	GBZ	None listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.