DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS
FDA 510(k) clearance K071427 · decided 2007-08-30
Clearance details
- K-number
- K071427
- Device name
- DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS
- Applicant
- Cardiovascular Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-05-23
- Decision date
- 2007-08-30
- Days to decision
- 99 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 |
| Diamondback 360, CSI ViperWire Orbital Atherectomy Guide Wire, REF: GW14335FRM. Sterilized recall (Z-1250-2009) | Cardiovascular Systems, Inc. | 2009-04-17 |