510(k) K014080
K014080 is an FDA 510(k) premarket notification submitted by Dideco S.P.A. for the device "APEX ADULT HOLLOWE FIBER OXYGENATOR". The FDA issued a decision of Substantially Equivalent on Jan 8, 2002. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Dideco S.P.A. has 32 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 8, 2002
- Date Received
- Dec 11, 2001
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Oxygenator, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4350
- Review Panel
- CV
- Submission Type
- 510(k)