Company ยท US
OriGen Biomedical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2012. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
20recalls (0 in 12 months)
17recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 17 |
| DQO | Catheter, Intravascular, Diagnostic | 2 |
| DWC | Controller, Temperature, Cardiopulmonary Bypass | 1 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 1 |
| KJA | Flask, Tissue Culture | 1 |
| KJG | Tube, Tissue Culture | 1 |
| LPZ | Container, Frozen Donor Tissue Storage | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 26, 2012 | K113869 | ORIGEN REINFORCED DUAL LUMEN CATHETER Origen Biomedical, Inc. | DWF |
| Aug 6, 2002 | K021702 | CRYOBAG, MODEL CB Origen Biomedical, Inc. | LPZ |
| Jun 8, 2001 | K003288 | ORIGEN DUAL LUMEN CATHETER Origen Biomedical, Inc. | DQO |
| Apr 20, 2001 | K003145 | ORIGEN BLADDER HOLDER Origen Biomedical, Inc. | DWC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 9, 2024 | OriGen Biomedical, Inc. Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF: RF-T15, and 60ml syringe on a female luer with 15cm sealed SCD tubing, REF: 15-RF60-T Open, Classified |
KJG | None listed |
| Apr 10, 2021 | OriGen Biomedical, Inc. Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N
The Evolve bag is made of Ethyl Vinyl Olefin (EVO) and contains no BPA or latex. The bag can be supplied with tubing
sets that can include Terminated |
KJA | None listed |
| Jun 24, 2019 | OriGen Biomedical, Inc. 3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only Terminated |
KFM | K170029 |
| Jun 4, 2019 | OriGen Biomedical, Inc. ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F Terminated |
DWF | K113869 |
| Jun 4, 2019 | OriGen Biomedical, Inc. ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV19F Terminated |
DWF | K113869 |
| Jun 4, 2019 | OriGen Biomedical, Inc. ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F Terminated |
DWF | K113869 |
| Jun 4, 2019 | OriGen Biomedical, Inc. ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV32F Terminated |
DWF | K113869 |
| Jun 4, 2019 | OriGen Biomedical, Inc. ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV23F Terminated |
DWF | K113869 |
| Jun 4, 2019 | OriGen Biomedical, Inc. ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16F Terminated |
DWF | K113869 |
| 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 | K113869 |
| 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 | K113869 |
| 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 | K113869 |
| 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 | K113869 |
| 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 | K113869 |
| 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 | K113869 |
| 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 | K113869 |
| 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 | K113869 |
| 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 | K113869 |
| 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 | K113869 |
| Oct 15, 2005 | Origen Biomedical, Inc Dual Lumen Cannula, 12Fr., sterile, disposable. Manufactured by OriGen Biomedical, 4020 S. Industrial Dr. #160, Austin, Texas USA 78744 Terminated |
DQO | None listed |