The following data is part of a premarket notification filed by Spectranetics, Inc. with the FDA for Spectranetics Turbo-elite Laser Atherectomy Catheters.
| Device ID | K170059 |
| 510k Number | K170059 |
| Device Name: | Spectranetics Turbo-Elite Laser Atherectomy Catheters |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | Spectranetics, Inc. 9965 Federal Drive Colorado Springs, CO 80921 |
| Contact | Rebecca Spelich |
| Correspondent | Rebecca Spelich Spectranetics, Inc. 9965 Federal Drive Colorado Springs, CO 80921 |
| Product Code | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-06 |
| Decision Date | 2017-04-07 |
| Summary: | summary |