IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR
FDA 510(k) clearance K032040 · decided 2003-07-09
Clearance details
- K-number
- K032040
- Device name
- IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR
- Applicant
- Dideco S.P.A.
- Decision
- Substantially Equivalent
- Date received
- 2003-07-01
- Decision date
- 2003-07-09
- Days to decision
- 8 days
- Clearance type
- Special
- Product code
- KFM
- Device class
- 2
- Regulation number
- 870.4360
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SYNERGY Perfusion Tubing Systems US Denver PHISIO, Sorin Group USA, Tubing set heart-lung recall (Z-0769-2012) | Sorin Group USA, Inc. | 2012-01-14 |