DIAMONDBACK 360 DBX
FDA 510(k) clearance K090521 · decided 2009-03-20
Clearance details
- K-number
- K090521
- Device name
- DIAMONDBACK 360 DBX
- Applicant
- Cardiovascular Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-02-26
- Decision date
- 2009-03-20
- Days to decision
- 22 days
- Clearance type
- Special
- Product code
- MCW
- Device class
- 2
- Regulation number
- 870.4875
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Saint Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Diamondback 360 Orbital Atherectomy Device, 1.50 LT Classic, Model #DB-150L, CSI Part # 70 recall (Z-2028-2009) | Cardiovascular Systems, Inc. | 2009-09-10 |