ORIGEN REINFORCED DUAL LUMEN CATHETER— 510(k) K113869

Clearance details

Applicant

Origen Biomedical, Inc.

Product code

Code DWF

Device class

Class 2

Regulation

21 CFR 870.4210

Advisory panel

Cardiovascular

Date received

2011-12-30

Decision date

2012-07-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Austin, TX, US

• K260195 — Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae2026-04-23
• K250937 — Venous Return Cannulae2026-03-11
• K260043 — Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)2026-02-23
• K253203 — Retrograde Coronary Sinus Perfusion Cannulae2026-02-19
• K253671 — Dual Stage Venous Cannulae2026-01-30

• K021702 — CRYOBAG, MODEL CB2002-08-06
• K003288 — ORIGEN DUAL LUMEN CATHETER2001-06-08
• K003145 — ORIGEN BLADDER HOLDER2001-04-20

Death

106

Injury

386

Malfunction

2,323

Total

2,815

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-0102-2019 — Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EOClass II·Terminated·OriGen Biomedical, Inc.·20180821
• Z-0179-2019 — Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures.Class II·Terminated·OriGen Biomedical, Inc.·20180821
• Z-0180-2019 — Reinforced Dual Lumen Cannula, 16Fr., REF: VV16F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures.Class II·Terminated·OriGen Biomedical, Inc.·20180821
• Z-0181-2019 — Reinforced Dual Lumen Cannula, 19Fr., REF: VV19F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures.Class II·Terminated·OriGen Biomedical, Inc.·20180821
• Z-0182-2019 — Reinforced Dual Lumen Cannula, 23Fr., REF: VV23F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures.Class II·Terminated·OriGen Biomedical, Inc.·20180821
• Z-0183-2019 — ECMO Reinforced Dual Lumen Cannula, 28Fr., REF: VV28F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures.Class II·Terminated·OriGen Biomedical, Inc.·20180821
• Z-0184-2019 — Reinforced Dual Lumen Cannula, 32Fr., REF: VV32F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures.Class II·Terminated·OriGen Biomedical, Inc.·20180821
• Z-0021-2018 — The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.Class I·Terminated·OriGen Biomedical, Inc.·20170802
• Z-1227-2019 — ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16FClass I·Terminated·OriGen Biomedical, Inc.·20170117
• Z-1228-2019 — ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV23FClass I·Terminated·OriGen Biomedical, Inc.·20170117
• Z-1229-2019 — ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV32FClass I·Terminated·OriGen Biomedical, Inc.·20170117
• Z-1230-2019 — ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13FClass I·Terminated·OriGen Biomedical, Inc.·20170117
• Z-1231-2019 — ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV19FClass I·Terminated·OriGen Biomedical, Inc.·20170117
• Z-1232-2019 — ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28FClass I·Terminated·OriGen Biomedical, Inc.·20170117
• Z-0269-2019 — REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 Product Usage: The OriGen RDLC catheter is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less.Class I·Terminated·OriGen Biomedical, Inc.·20150330
• Z-1456-2015 — OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE Manufactured by: OriGen Biomedical. OriGene VV13F Reinforced Dual Lumen Catheter indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less.Class I·Terminated·OriGen Biomedical, Inc.·20150330

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113869.