510(k) K070213
K070213 is an FDA 510(k) premarket notification submitted by Rand S.R.L. for the device "PERFORMER CBP SYSTEM". The FDA issued a decision of Substantially Equivalent on March 21, 2007. The device falls under product code DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4220. Rand S.R.L. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 21, 2007
- Date Received
- January 22, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Console, Heart-Lung Machine, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4220
- Review Panel
- CV
- Submission Type