K003145 is an FDA 510(k) clearance for the ORIGEN BLADDER HOLDER. This device is classified as a Controller, Temperature, Cardiopulmonary Bypass (Class II - Special Controls, product code DWC).
Submitted by Origen Biomedical, Inc. (Austin, US). The FDA issued a Cleared decision on April 20, 2001, 192 days after receiving the submission on October 10, 2000.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4250. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf)..
| 510(k) Number | K003145 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 10, 2000 |
| Decision Date | April 20, 2001 |
| Days to Decision | 192 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DWC — Controller, Temperature, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4250 |
| Definition | If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf). |