510(k) K010117
K010117 is an FDA 510(k) premarket notification submitted by Cardiothoracic Systems, Inc. for the device "GUIDANT AXIUS CORONARY SHUNT". The FDA issued a decision of Substantially Equivalent on April 4, 2001. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Cardiothoracic Systems, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 4, 2001
- Date Received
- January 16, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clamp, Vascular
- Device Class
- Class II
- Regulation Number
- 870.4450
- Review Panel
- CV
- Submission Type