Submission Details
| 510(k) Number | K022857 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Special
PUMP TUBING WITH X-COATING
Sep 2002
Decision
22d
Days
Class 2
Risk
About This 510(k) Submission
K022857 is an FDA 510(k) clearance for the PUMP TUBING WITH X-COATING, 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 review panel. Regulated under 21 CFR 870.4390.
Device Classification
| Product Code | DWE — Tubing, Pump, Cardiopulmonary Bypass |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.4390 |
Manufacturer
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