510(k) K142546
K142546 is an FDA 510(k) premarket notification submitted by Spectranetics, Inc. for the device "TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath". The FDA issued a decision of Substantially Equivalent on September 25, 2014. The device falls under product code DRE (Dilator, Vessel, For Percutaneous Catheterization), a Class II device regulated under 21 CFR 870.1310. Spectranetics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 25, 2014
- Date Received
- September 10, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dilator, Vessel, For Percutaneous Catheterization
- Device Class
- Class II
- Regulation Number
- 870.1310
- Review Panel
- CV
- Submission Type