510(k) K133631
K133631 is an FDA 510(k) premarket notification submitted by Spectranetics Corporation for the device "LEXIPLIANT DILATOR SHEATH SET". The FDA issued a decision of Substantially Equivalent on March 27, 2014. The device falls under product code DRE (Dilator, Vessel, For Percutaneous Catheterization), a Class II device regulated under 21 CFR 870.1310. Spectranetics Corporation has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 27, 2014
- Date Received
- November 26, 2013
- 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