TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM
FDA 510(k) clearance K140775 · decided 2014-07-23
Clearance details
- K-number
- K140775
- Device name
- TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM
- Applicant
- Spectranetics Corporation
- Decision
- Substantially Equivalent
- Date received
- 2014-03-28
- Decision date
- 2014-07-23
- Days to decision
- 117 days
- Clearance type
- Traditional
- Product code
- MCW
- Device class
- 2
- Regulation number
- 870.4875
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Colorado Springs, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152, 417 recall (Z-0661-2017) | Spectranetics Corporation | 2016-11-28 |
| ELCA Coronary Atherectomy Catheter. Models: 110-001, 110-002, 110-004, 114-009, 117-016, 1 recall (Z-0662-2017) | Spectranetics Corporation | 2016-11-28 |
| Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the superior vena c recall (Z-0663-2017) | Spectranetics Corporation | 2016-11-28 |