Submission Details
| 510(k) Number | K150542 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 03, 2015 |
| Decision Date | May 01, 2015 |
| Days to Decision | 59 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
Terumo Pump Tubing
May 2015
Decision
59d
Days
Class 2
Risk
About This 510(k) Submission
K150542 is an FDA 510(k) clearance for the Terumo Pump Tubing, a Tubing, Pump, Cardiopulmonary Bypass (Class II — Special Controls, product code DWE), submitted by Terumo Cardiovascular Systems Corporation (Ashland, US). The FDA issued a Cleared decision on May 1, 2015, 59 days after receiving the submission on March 3, 2015. 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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