The following data is part of a premarket notification filed by Origen Biomedical, Inc. with the FDA for Origen Reinforced Dual Lumen Catheter.
| Device ID | K113869 |
| 510k Number | K113869 |
| Device Name: | ORIGEN REINFORCED DUAL LUMEN CATHETER |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | Origen Biomedical, Inc. 7000 BURLESON ROAD BLDG D Austin, TX 78744 |
| Contact | Richard Martin |
| Correspondent | Richard Martin Origen Biomedical, Inc. 7000 BURLESON ROAD BLDG D Austin, TX 78744 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-30 |
| Decision Date | 2012-07-26 |
| Summary: | summary |