The following data is part of a premarket notification filed by Spectranetics Corporation with the FDA for Lexipliant Dilator Sheath Set.
| Device ID | K133631 |
| 510k Number | K133631 |
| Device Name: | LEXIPLIANT DILATOR SHEATH SET |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | SPECTRANETICS CORPORATION 9965 FEDERAL DRIVE Colorado Springs, CO 80921 -3617 |
| Contact | Stacey A Strand |
| Correspondent | Stacey A Strand SPECTRANETICS CORPORATION 9965 FEDERAL DRIVE Colorado Springs, CO 80921 -3617 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-26 |
| Decision Date | 2014-03-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M204555513AA0 | K133631 | 000 |
| M2045500100 | K133631 | 000 |
| M2045500110 | K133631 | 000 |
| M2045500130 | K133631 | 000 |
| M2045555080 | K133631 | 000 |
| M2045555100 | K133631 | 000 |
| M2045555110 | K133631 | 000 |
| M2045555130 | K133631 | 000 |
| M204550008AA0 | K133631 | 000 |
| M204550010AA0 | K133631 | 000 |
| M204550011AA0 | K133631 | 000 |
| M204550013AA0 | K133631 | 000 |
| M204555508AA0 | K133631 | 000 |
| M204555510AA0 | K133631 | 000 |
| M204555511AA0 | K133631 | 000 |
| M2045500080 | K133631 | 000 |