FDA.reportPublic FDA data

Pneumothorax catheter insertion set

Definition
A collection of devices used to puncture the chest wall to enable insertion of a dedicated catheter for the aspiration of a simple pneumothorax or decompression of a tension pneumothorax. It typically consists of a scalpel to make a stab incision and a needle to assist the entry of the catheter with obturator assembly (to protect the internal organs upon entry). Once the catheter is in place, the needle is retracted to allow the flow of air/fluid from within the chest cavity. The set may contain suture for the attachment of the catheter to the skin. It is typically used for accident and emergency (A&E) situations (immediate care or chest crush injury). This is a single-use device.
GUDID devices
234
Last updated
2026-07-17 21:59:43

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00817640020462Thora-Vent Thoracic VentURESIL, LLCOTW11-132022-06-02
H862TVST0Thora-Vent Thoracic VentURESIL, LLCTVST2016-09-07
M689HHCTUINK01050Chest Tube Insertion KitSafeguard US Operating, LLC052026-05-27
M689HHCTUINK0105050Chest Tube Insertion Kit Cast of 5Safeguard US Operating, LLC052026-05-27
00193494450830ON-Q* Pain Relief SystemAvanos Medical, Inc.450832020-06-08
00685404000797Sterling Medical Products APOLLO MEDICAL PRODUCTS CORP.N10492019-08-02
00801902002693ARROWTELEFLEX INCORPORATEDIPN0326152016-09-16
00801902002709ARROWTELEFLEX INCORPORATEDIPN0330112016-09-16
00801902004161ARROWTELEFLEX INCORPORATEDIPN0325992016-09-16
00801902004789ARROWTELEFLEX INCORPORATEDIPN0338372016-09-16
00801902004796ARROWTELEFLEX INCORPORATEDIPN0338382016-09-16
00801902004802ARROWTELEFLEX INCORPORATEDIPN0338392016-09-16
00801902043849ARROWTELEFLEX INCORPORATEDIPN0341662016-09-16
00801902053275ARROWTELEFLEX INCORPORATEDIPN0341762016-09-16
00801902071736ARROWTELEFLEX INCORPORATEDIPN0342002016-09-16
00801902079893ARROWTELEFLEX INCORPORATEDIPN0341702016-09-16
00801902097897ARROWTELEFLEX INCORPORATEDIPN0326002016-09-16
00801902097965ARROWTELEFLEX INCORPORATEDIPN0326162016-09-16
00801902099587ARROWTELEFLEX INCORPORATEDIPN0330122016-09-16
00810094576394CuraplexBOUND TREE MEDICAL, LLC2160-205002023-11-10
00817640020752Thora-Vent Thoracic VentURESIL, LLCTV11-102022-03-24
00817640020769Thora-Vent Thoracic VentURESIL, LLCTV11-132022-03-24
00817640020776Thora-Vent Thoracic VentURESIL, LLCTV13-102022-03-24
00817640020783Thora-Vent Thoracic VentURESIL, LLCTV13-132022-03-24
00817640020790Thora-Vent Thoracic VentURESIL, LLCTVOCP2022-06-03
00817640020806Thora-Vent Thoracic VentURESIL, LLCTVST2022-06-03
00817640020820Thora-Vent Thoracic VentURESIL, LLCTVOCP2022-09-15
00850056748520"FORWARD EMS Chest Tube Insertion Kit, 28Fr, 8"" Pean"INTEGRATED MEDCRAFT LLC4818-328282025-10-15
00850063404457easycareSynchronis Medical, LLC4818-900002025-12-08
00860000925365ForwardSynchronis Medical, LLC4818-320022020-08-13
00860000925396ForwardSynchronis Medical, LLC4818-320122020-08-13
05055270900135RocketROCKET MEDICAL PLCR54544-18-002017-01-06
05055270920942RocketROCKET MEDICAL PLCR54544-12-SG2017-01-06
05055270920959RocketROCKET MEDICAL PLCR54544-18-SG2017-01-06
05055270920966RocketROCKET MEDICAL PLCR54544-12-PK2017-01-06
05055270920973RocketROCKET MEDICAL PLCR54544-18-PK2016-09-12
05055270921185RocketROCKET MEDICAL PLCR54549-16-PK2017-01-19
05055270921192RocketROCKET MEDICAL PLCR54549-20-PK2017-01-19
05055270921222RocketROCKET MEDICAL PLCR54549-28-PK2017-01-19
05055270921314RocketROCKET MEDICAL PLCR54544-12-002017-01-06
05055270964700RocketROCKET MEDICAL PLCR54960-PG-FX2017-01-19
05055270965271RocketROCKET MEDICAL PLCR54960-DG-FX2017-01-19
05055270966230RocketROCKET MEDICAL PLCR51549-18-SG2017-01-05
05055270966261RocketROCKET MEDICAL PLCR51549-18-PK2016-09-19
05055270966292RocketROCKET MEDICAL PLCR51549-16-PK2016-09-19
05055270966322RocketROCKET MEDICAL PLCR51549-12-SG2017-01-05
05055270966353RocketROCKET MEDICAL PLCR51549-12-PK2016-09-19
05055270966384RocketROCKET MEDICAL PLCR51549-28-PK2016-09-19
05055270966414RocketROCKET MEDICAL PLCR51549-20-PK2016-09-19
05055270966476RocketROCKET MEDICAL PLCR51549-26-PK2016-09-19
05055270966650RocketROCKET MEDICAL PLCR54544-GW2017-01-09
05055270967404RocketROCKET MEDICAL PLCR54544-14-LX2017-01-06
05055270967558RocketROCKET MEDICAL PLCR54544-WB2018-01-31
05055270972262RocketROCKET MEDICAL PLCR51554-08-PK2016-09-19
05055270972293RocketROCKET MEDICAL PLCR51554-06-PK2016-09-19
05055270973450RocketROCKET MEDICAL PLCR51549-24-PK2016-09-20
10801902043846ARROWTELEFLEX INCORPORATEDIPN0341662017-07-13
10801902114867ARROWTELEFLEX INCORPORATEDIPN0365432016-09-16
10801902120127ARROWTELEFLEX INCORPORATEDIPN0369772016-09-16
10801902120134ARROWTELEFLEX INCORPORATEDIPN0368312016-09-16
10801902120141ARROWTELEFLEX INCORPORATEDIPN0368222016-09-16
10801902120196ARROWTELEFLEX INCORPORATEDIPN0370882016-09-16
10801902120202ARROWTELEFLEX INCORPORATEDIPN0371402016-09-16
10801902126822ARROWTELEFLEX INCORPORATEDIPN0013132016-09-16
10801902142914ARROWTELEFLEX INCORPORATEDIPN0386232019-03-07
10801902145106ARROWTELEFLEX INCORPORATEDIPN0392802019-03-07
10801902145113ARROWTELEFLEX INCORPORATEDIPN0392812019-03-07
10801902145120ARROWTELEFLEX INCORPORATEDIPN0392822019-03-07
10801902145434ARROWTELEFLEX INCORPORATEDIPN0397282019-03-07
10801902145823ARROWTELEFLEX INCORPORATEDIPN0398062019-07-09
10801902156232ARROWTELEFLEX INCORPORATEDIPN0554552019-05-09
10801902193992ARROWTELEFLEX INCORPORATEDIPN9203562022-11-08
10801902194647ARROWTELEFLEX INCORPORATEDIPN9204222022-11-08
10801902197976ARROWTELEFLEX INCORPORATEDIPN9208042022-11-09
10801902203134ARROWTELEFLEX INCORPORATEDIPN9228982023-06-05
10801902209013ARROWTELEFLEX INCORPORATEDIPN9248762022-04-27
10801902209105ARROWTELEFLEX INCORPORATEDIPN9248812022-05-26
15060498450192Motion Medical DistributingHaslam Medical, Inc.16812016-12-06
15060498451441Motion Medical DistributingHaslam Medical, Inc.16882017-04-20
15060498452035Motion Medical DistributingHaslam Medical, Inc.16892019-11-25