TIGHTRAIL MINI
FDA 510(k) clearance K141131 · decided 2014-05-23
Clearance details
- K-number
- K141131
- Device name
- TIGHTRAIL MINI
- Applicant
- Spectranetics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-05-01
- Decision date
- 2014-05-23
- Days to decision
- 22 days
- Clearance type
- Special
- Product code
- DRE
- Device class
- 2
- Regulation number
- 870.1310
- 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
No recalls on record reference this clearance.