APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
FDA 510(k) clearance K020997 · decided 2002-04-04
Clearance details
- K-number
- K020997
- Device name
- APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
- Applicant
- Dideco S.P.A.
- Decision
- Substantially Equivalent
- Date received
- 2002-03-28
- Decision date
- 2002-04-04
- Days to decision
- 7 days
- Clearance type
- Special
- Product code
- DTZ
- Device class
- 2
- Regulation number
- 870.4350
- 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 |
|---|---|---|
| Apex SMART PHisio Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: recall (Z-0761-2012) | Sorin Group USA, Inc. | 2012-01-14 |
| Apex Phisio Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin recall (Z-0762-2012) | Sorin Group USA, Inc. | 2012-01-14 |