510(k) K004001
K004001 is an FDA 510(k) premarket notification submitted by Dideco for the device "MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR". The FDA issued a decision of Substantially Equivalent on Oct 4, 2001. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Dideco has 32 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 4, 2001
- Date Received
- Dec 26, 2000
- Clearance Type
- Abbreviated
- 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)