The following data is part of a premarket notification filed by Spectranetics Corp. with the FDA for 2.5mm Turbo Elite 035, 2.3mm Turbo Elite 035.
| Device ID | K123632 |
| 510k Number | K123632 |
| Device Name: | 2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035 |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | SPECTRANETICS CORP. 9965 Federal Drive Colorado Springs, CO 80921 |
| Contact | Christine Godleski |
| Correspondent | Christine Godleski SPECTRANETICS CORP. 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 | 2012-11-23 |
| Decision Date | 2013-01-25 |
| Summary: | summary |