510(k) K050447
K050447 is an FDA 510(k) premarket notification submitted by Dideco S.R.L. for the device "PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR". The FDA issued a decision of Substantially Equivalent on March 8, 2005. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Dideco S.R.L. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 8, 2005
- Date Received
- February 22, 2005
- 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