510(k) K953835
K953835 is an FDA 510(k) premarket notification submitted by Dideco S.R.L. for the device "LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR". The FDA issued a decision of Substantially Equivalent on Mar 15, 1996. 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 32 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 15, 1996
- Date Received
- Aug 16, 1995
- Clearance Type
- Traditional
- 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)