K022857 is an FDA 510(k) clearance for the PUMP TUBING WITH X-COATING. This device is classified as a Tubing, Pump, Cardiopulmonary Bypass (Class II - Special Controls, product code DWE).
Submitted by Terumo Cardiovascular Systems Corporation (Elkton, US). The FDA issued a Cleared decision on September 19, 2002, 22 days after receiving the submission on August 28, 2002.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4390.
| 510(k) Number | K022857 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 2002 |
| Decision Date | September 19, 2002 |
| Days to Decision | 22 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DWE — Tubing, Pump, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4390 |