The following data is part of a premarket notification filed by Spectranetics Corp. with the FDA for Lexiconture Mechanical Dilator Sheath Set.
| Device ID | K140047 |
| 510k Number | K140047 |
| Device Name: | LEXICONTURE MECHANICAL DILATOR SHEATH SET |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | SPECTRANETICS CORP. 9965 Federal Drive Colorado Springs, CO 80921 |
| Contact | Pharoah Garma |
| Correspondent | Pharoah Garma SPECTRANETICS CORP. 9965 Federal Drive Colorado Springs, CO 80921 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-09 |
| Decision Date | 2014-04-09 |
| Summary: | summary |