510(k) K131618
K131618 is an FDA 510(k) premarket notification submitted by Terumo Cardiovascular Systems Corporation for the device "LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYST". The FDA issued a decision of Substantially Equivalent on September 27, 2013. The device falls under product code DWB (Pump, Blood, Cardiopulmonary Bypass, Roller Type), a Class II device regulated under 21 CFR 870.4370. Terumo Cardiovascular Systems Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 2013
- Date Received
- June 3, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Blood, Cardiopulmonary Bypass, Roller Type
- Device Class
- Class II
- Regulation Number
- 870.4370
- Review Panel
- CV
- Submission Type