510(k) K131041
K131041 is an FDA 510(k) premarket notification submitted by Terumo Cardiovascular Systems Corp. for the device "ADVANCED PERFUSION SYSTEM 1". The FDA issued a decision of Substantially Equivalent on February 20, 2014. The device falls under product code DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4220. Terumo Cardiovascular Systems Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 20, 2014
- Date Received
- April 15, 2013
- 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