Submission Details
| 510(k) Number | K032040 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 01, 2003 |
| Decision Date | July 09, 2003 |
| Days to Decision | 8 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR
Jul 2003
Decision
8d
Days
Class 2
Risk
About This 510(k) Submission
K032040 is an FDA 510(k) clearance for the IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR, a Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (Class II — Special Controls, product code KFM), submitted by Dideco S.P.A. (Waltham, US). The FDA issued a Cleared decision on July 9, 2003, 8 days after receiving the submission on July 1, 2003. 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 |
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