ATRIUM THORACIC CATHETER— 510(k) K831931

Clearance details

Applicant

Atrium Medical Corp.

Product code

Code GBZ

Device class

Class 1

Regulation

21 CFR 878.4200

Advisory panel

General, Plastic Surgery

Date received

1983-06-15

Decision date

1983-10-04

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Walker, MI, US

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• K944790 — FLEXIBLE LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER1994-11-29
• K942450 — ENDOPATH1994-08-05
• K932228 — MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER1993-08-10
• K926217 — TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE1993-07-13

• K130131 — EDRAIN CHEST DRAINAGE SYSTEM2013-02-28
• K122138 — ATRIUM FLIXENE IFG VASCULAR GRAFT2012-08-17
• K121070 — C-QUR RPM MESH2012-04-26
• K113112 — CLEARWAY RX NB CATHETER2011-11-17
• K102596 — ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT2010-10-05

Death

2

Total

2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0484-2024 — Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.Class II·Ongoing·Atrium Medical Corporation·20230929
• Z-0560-2019 — Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128Class II·Terminated·Atrium Medical Corporation·20181012
• Z-1221-2017 — Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008Class II·Terminated·Atrium Medical Corporation·20170120
• Z-1222-2017 — Atrium PVC 10 Fr Straight Thoracic Catheter Code Number: 8010Class II·Terminated·Atrium Medical Corporation·20170120
• Z-0576-2017 — 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.Class II·Terminated·Atrium Medical Corporation·20161026
• Z-0577-2017 — 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.Class II·Terminated·Atrium Medical Corporation·20161026
• Z-0578-2017 — 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.Class II·Terminated·Atrium Medical Corporation·20161026
• Z-0579-2017 — 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.Class II·Terminated·Atrium Medical Corporation·20161026
• Z-0580-2017 — 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.Class II·Terminated·Atrium Medical Corporation·20161026
• Z-0581-2017 — 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.Class II·Terminated·Atrium Medical Corporation·20161026
• Z-0582-2017 — 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.Class II·Terminated·Atrium Medical Corporation·20161026
• Z-0583-2017 — 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.Class II·Terminated·Atrium Medical Corporation·20161026
• Z-2346-2015 — Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236Class II·Terminated·Atrium Medical Corporation·20150619

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K831931.