Submission Details
| 510(k) Number | K133265 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 23, 2013 |
| Decision Date | November 12, 2013 |
| Days to Decision | 20 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
QUADROX-IR ADULT AND SMALL ADULT
Nov 2013
Decision
20d
Days
Class 2
Risk
About This 510(k) Submission
K133265 is an FDA 510(k) clearance for the QUADROX-IR ADULT AND SMALL ADULT, a Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (Class II — Special Controls, product code KFM), submitted by Maquet Cardiopulmonary, AG (Wayne, US). The FDA issued a Cleared decision on November 12, 2013, 20 days after receiving the submission on October 23, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4360.
Device Classification
| Product Code | KFM — Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.4360 |
Manufacturer
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