510(k) K000274
K000274 is an FDA 510(k) premarket notification submitted by Medtronic Cardiac Surgical Products for the device "EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA WITH GUIDEWIRE". The FDA issued a decision of Substantially Equivalent on February 10, 2000. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. Medtronic Cardiac Surgical Products has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 10, 2000
- Date Received
- January 31, 2000
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4210
- Review Panel
- CV
- Submission Type