LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT/NEWBORN HOLLOW FIBER OXYGENATOR
FDA 510(k) clearance K991737 · decided 2000-02-17
Clearance details
- K-number
- K991737
- Device name
- LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT/NEWBORN HOLLOW FIBER OXYGENATOR
- Applicant
- Dideco S.P.A.
- Decision
- Substantially Equivalent
- Date received
- 1999-05-21
- Decision date
- 2000-02-17
- Days to decision
- 272 days
- Clearance type
- Traditional
- 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 |
|---|---|---|
| Dideco, D901 Lilliput 1, Close Phisio, Sterile EO, REF 05252, Manufacturer: Sorin Group It recall (Z-2469-2008) | Sorin Group USA, Inc. | 2008-09-30 |