510(k) K113869 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
ORIGEN REINFORCED DUAL LUMEN CATHETER
| Applicant | Origen Biomedical, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Jul 26, 2012 |
| Received | Dec 30, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113869
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 4, 2019 | OriGen Biomedical, Inc. ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16F Terminated |
DWF | None listed |
| Jun 4, 2019 | OriGen Biomedical, Inc. ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV23F Terminated |
DWF | None listed |
| Jun 4, 2019 | OriGen Biomedical, Inc. ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV32F Terminated |
DWF | None listed |
| Jun 4, 2019 | OriGen Biomedical, Inc. ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F Terminated |
DWF | None listed |
| Jun 4, 2019 | OriGen Biomedical, Inc. ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV19F Terminated |
DWF | None listed |
| Jun 4, 2019 | OriGen Biomedical, Inc. ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F Terminated |
DWF | None listed |
| Nov 7, 2018 | OriGen Biomedical, Inc. 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 drainag Terminated |
DWF | None listed |
| Aug 21, 2018 | OriGen Biomedical, Inc. 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 Terminated |
DWF | None listed |
| Aug 21, 2018 | OriGen Biomedical, Inc. 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 Terminated |
DWF | None listed |
| Aug 21, 2018 | OriGen Biomedical, Inc. 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 o Terminated |
DWF | None listed |
| Aug 21, 2018 | OriGen Biomedical, Inc. 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 Terminated |
DWF | None listed |
| Aug 21, 2018 | OriGen Biomedical, Inc. 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-infusi Terminated |
DWF | None listed |
| Aug 21, 2018 | OriGen Biomedical, Inc. 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 o Terminated |
DWF | None listed |
| Aug 21, 2018 | OriGen Biomedical, Inc. Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO Terminated |
DWF | None listed |
| Oct 20, 2017 | OriGen Biomedical, Inc. 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 Terminated |
DWF | None listed |
| Apr 23, 2015 | OriGen Biomedical, Inc. 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 sin Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.