510(k) K022857
K022857 is an FDA 510(k) premarket notification submitted by Terumo Cardiovascular Systems Corporation for the device "PUMP TUBING WITH X-COATING". The FDA issued a decision of Substantially Equivalent on September 19, 2002. The device falls under product code DWE (Tubing, Pump, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4390. Terumo Cardiovascular Systems Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 19, 2002
- Date Received
- August 28, 2002
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubing, Pump, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4390
- Review Panel
- CV
- Submission Type