510(k) K090521
K090521 is an FDA 510(k) premarket notification submitted by Cardiovascular Systems, Inc. for the device "DIAMONDBACK 360 DBX". The FDA issued a decision of Substantially Equivalent on March 20, 2009. The device falls under product code MCW (Catheter, Peripheral, Atherectomy), a Class II device regulated under 21 CFR 870.4875. Cardiovascular Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 20, 2009
- Date Received
- February 26, 2009
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Peripheral, Atherectomy
- Device Class
- Class II
- Regulation Number
- 870.4875
- Review Panel
- CV
- Submission Type