The following data is part of a premarket notification filed by Spectranetics Corporation with the FDA for Turbo-elite Atherectomy Catheters, Turbo Tandem System.
| Device ID | K140775 |
| 510k Number | K140775 |
| Device Name: | TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | SPECTRANETICS CORPORATION 9965 FEDERAL DRIVE Colorado Springs, CO 80921 -3617 |
| Contact | Amanda Johnson |
| Correspondent | Amanda Johnson SPECTRANETICS CORPORATION 9965 FEDERAL DRIVE Colorado Springs, CO 80921 -3617 |
| Product Code | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-28 |
| Decision Date | 2014-07-23 |
| Summary: | summary |