STEALTH 360 ORBITAL PAD SYSTEM
FDA 510(k) clearance K110389 · decided 2011-03-11
Clearance details
- K-number
- K110389
- Device name
- STEALTH 360 ORBITAL PAD SYSTEM
- Applicant
- Cardiovascular Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-02-10
- Decision date
- 2011-03-11
- Days to decision
- 29 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 |
|---|---|---|
| CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Numbe recall (Z-1959-2012) | Cardiovascular Systems, Inc. | 2012-07-09 |