ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD
FDA 510(k) clearance K151260 · decided 2015-06-10
Clearance details
- K-number
- K151260
- Device name
- ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD
- Applicant
- Cardiovascular System, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-05-12
- Decision date
- 2015-06-10
- 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
+ Add to Predicate Builder ◉ Watch Cardiovascular System
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, Part Number: 7-10026-01, recall (Z-1877-2017) | Cardiovascular Systems Inc | 2017-04-10 |